Melody Lam

Senior Data Engineer | Medical Device Startup | San Diego, CA (Hybrid, 3+ days onsite) A venture-backed startup developing a novel wearable medical device is hiring a Senior Data Engineer. The company is running multiple clinical trials leading toward a pivotal FDA submission. THE ROLE This role owns the company's data architecture end to end and reports to the Director of Data Science. The work starts upstream: you'll make sure the right data is collected in the first place by turning clinical, regulatory and commercial needs into instrumentation specs, then build the infrastructure that makes that data useful. It's hands-on. You'll design schemas and implement them, contribute to product concepts, and build several systems from scratch. The data includes telemetry from embedded and mobile systems with intermittent connectivity, clinical outcomes, EDC data, and evolving manufacturing and production systems. WHAT YOU'LL DO Define what data to collect from the device, manufacturing and business operations, and translate those needs into instrumentation specs and data models Design and own data schemas that serve analytical, regulatory and operational users, and document the tradeoffs Build and maintain transformation pipelines on Google Cloud and BigQuery Own the warehouse layer, including schema implementation, versioning, access controls and data quality monitoring Keep lineage and transformation logic traceable to a standard that holds up in a regulatory audit Build integrations with EDC systems and third-party device data Produce CDISC-compliant datasets (SDTM/ADaM) for regulatory submissions Build manufacturing data infrastructure: lot tracking, supply chain, process control and non-destructive testing records Define data quality metrics and checks, own the fixes, and step into analysis when the team needs it WHAT YOU BRING 7+ years of data engineering experience, with a track record of owning production data systems end to end Experience defining data models and instrumentation requirements upstream of pipeline development Strong Python and SQL, plus working knowledge of cloud data platforms (the stack is Google Cloud, BigQuery and Firestore) Strong data modeling skills, with the judgment to serve multiple users and make tradeoffs explicit Experience turning business and scientific requirements into specs across data science, engineering, operations, clinical and regulatory teams Clear, direct communication with non-technical stakeholders NICE TO HAVE Experience in a regulated industry (medical devices, pharma or clinical research) where auditability and traceability are required Familiarity with CDISC (SDTM/ADaM) or clinical trial data formats Experience with EDC systems such as Castor, REDCap, Medidata Rave or Veeva Vault Exposure to 21 CFR Part 11 Experience with manufacturing, supply chain or operational data systems Background in medical devices, wearables or digital health MS in computer science, data engineering, biomedical informatics or a related field Candidates must be authorized to work in the U.S. without sponsorship and must live within commuting distance of San Diego.

Clinical Data Analyst | Medical Device Startup | San Diego, CA (Hybrid, 3+ days onsite) A venture-backed startup developing a novel wearable medical device is hiring a Clinical Data Analyst. The company is running multiple clinical trials leading toward a pivotal FDA submission. THE ROLE This role owns clinical trial monitoring, analysis and reporting, and reports to the Director of Data Science. You'll ramp up alongside a senior data scientist to take over the existing clinical reporting pipelines and dashboards (SQL, Python, TypeScript, Terraform), then own their further development. As the company approaches commercial scale, the role will expand into manufacturing, quality and business analytics. WHAT YOU'LL DO Monitor clinical trial data across active studies every day, including the trials supporting the pivotal FDA submission Own and extend the clinical monitoring dashboard, covering clinical outcomes, device performance, safety signals and data completeness Build monitoring tools for different user groups: internal clinical and regulatory teams, CROs, and site PIs and coordinators Define data quality checks, and triage and escalate anomalies, missing data and out-of-range values Produce recurring and ad hoc analyses of clinical outcomes, device performance and safety summaries Write reports for clinical, regulatory and leadership audiences, and contribute to regulatory submissions and publications Support execution of statistical analysis plans and run HEOR analyses for payers Write and own the SQL that turns warehoused clinical data into analysis-ready datasets Manage a visible queue of analytics requests, set priorities and commit to delivery dates Document analytical methods, dataset definitions and reporting standards WHAT YOU BRING 5+ years in data analysis, clinical analytics or biostatistics support within medical devices, pharma or clinical research Working knowledge of clinical trial methodology: endpoints, protocol adherence, safety monitoring, database lock and GCP Hands-on experience with clinical trial datasets, including EDC outputs and device data Strong SQL skills, including joins, window functions and data modeling, plus BigQuery or a comparable cloud data warehouse Proficiency in Python or R, with work that is clean and reproducible Experience building and maintaining dashboards that other people rely on Ownership of analytical workstreams from start to finish while juggling competing deadlines Clear written and verbal communication with both technical and non-technical audiences Comfort working within regulated documentation and traceability requirements NICE TO HAVE Experience with wearable or connected medical device data Contributions to FDA submissions or regulatory-facing clinical reports Familiarity with CDISC (SDTM/ADaM), HEOR modeling or EDC platforms such as Castor MS in biostatistics, epidemiology, biomedical engineering, data science or a related field Candidates must be authorized to work in the U.S. without sponsorship and must live within commuting distance of San Diego.

Director of Product Quality Engineering | San Diego, CA (100% onsite) Summary We've been exclusively retained by an established diagnostics company to find a Director of Product Quality to lead its San Diego site's quality engineering and quality control organization. It's a hands-on leadership role for an engineer at heart: someone with deep validation and statistics expertise who can answer the tough technical questions, mentor a large team, and stay calm and credible during FDA inspections. The site is in a period of growth and change, having recently added several key leaders that are incredibly high caliber. You'd join a leadership team of decision makers and play a key role in raising the bar on quality across the site, with real room to grow. 💰 $200K–$260K base + bonus and industry-leading benefits Scope Leads a 36-person Quality Engineering and Quality Control organization 4 direct reports: 2 Senior Managers and 2 Specialized Engineers Oversees: incoming QC, supplier quality, Quality Control, design quality, and product quality and reliability Responsibilities Lead, develop and mentor a team of people leaders and engineers, and be the technical leader the team looks up to Serve as the site's subject matter expert on statistics and process validation, guiding the team on capability analysis, SPC and validation strategy week to week Oversee process validation, design controls, design quality and ISO 14971 risk management for new and sustaining products Sit on the site's CAPA Review Board alongside senior Operations and R&D leaders, driving root cause rigor and CAPA effectiveness across all phases Maintain oversight of nonconformance management (NCRs handled by QC) Lead FDA and ISO inspection readiness, and act as a calm, credible point of contact during inspections and audits Partner with Supply Chain and R&D on supplier selection, auditing and performance monitoring Champion Lean Six Sigma and 5S initiatives across the site Work closely with Manufacturing, Operations, R&D and Regulatory to improve quality and business performance Requirements BS in Engineering strongly preferred; BS in a technical discipline required 15+ years of quality engineering and quality control experience in medical device or IVD manufacturing (FDA/ISO 13485) 10+ years of people leadership, including managing managers Hands-on validation experience, including authoring process validation protocols (IQ/OQ/PQ) and leading validation strategy Expert-level statistics in practice: process capability (Cpk/Ppk), SPC, DOE and sampling plans Strong foundation in ISO 14971 risk management, CAPA and root cause investigation Direct experience leading or supporting FDA inspections Working knowledge of mechanical inspection, engineering drawings, GD&T and tolerancing ASQ CQE strongly preferred; Six Sigma Black Belt a plus Lean / 5S experience a plus What success looks like Credible and hands-on: can answer technical questions on validation, statistics and drawings, not just delegate them Calm under pressure: unruffled during inspections, and a steady mentor to the team Courageous and transparent: comfortable challenging and being challenged in a room of senior decision makers Influential: builds trust and alignment across Operations, R&D and Quality

🚨 Hiring: Senior / Staff Manufacturing Engineer | San Diego, CA I'm partnering with a venture-backed medical device startup developing a novel wearable device. They're already in clinical studies and building product on their own pilot line, and they're looking for a hands-on Manufacturing Engineer to own that line as they scale toward larger trials and commercial launch. This is an engineering role first. Your main focus will be manufacturing engineering, fixture design and equipment, with the added ownership of running a small, high-performing pilot line. You won't be starting from zero: the line is up and running, and the opportunity is to solve problems, optimize, and build in quality that will scale. 📍 San Diego, CA | Onsite 💰 $130K–$160K base + equity 🎚️ Senior or Staff level, 4–7+ years of experience 🚚 Relocation assistance available What you'll do Own day-to-day pilot line operations, including build planning, material forecasting and tracking output against plan Train and develop two high-performing operators into line leads Design and build fixtures and equipment for small electromechanical and single-use components Troubleshoot build issues and drive practical improvements in yield and efficiency Source and bring new equipment online, such as heat sealers, adhesive dispensers and label printers Own calibration, maintenance and good documentation practices on the line Write and execute validations (IQ/OQ/PQ, PFMEA, TMV) and support cleanroom qualification Shift toward scale-up and automation as the company builds out a full operations team over the next 1–2 years What you'll bring BS in Mechanical Engineering or a related field 4–7+ years of hands-on manufacturing engineering experience in medical devices, including calibration, process validation and good documentation practices Experience taking a product from development into production Fixtures you designed that went into daily production use Experience training operators directly on the line Exposure to both established, larger-scale production lines and fast-moving, scrappy R&D environments Proficiency in SolidWorks Strong problem solver who is comfortable wearing multiple hats and works well with people Bonus: cleanroom and ESD experience Why this role Build the manufacturing foundation for a product that will change patients' daily lives High ownership and visibility in a lean, mission-driven team Meaningful equity at an early stage

We're hiring a hands-on Staff Quality Engineer to build a quality system from the ground up as assay, consumable and instrument programs move from concept through design transfer and commercialization. This is a true builder role. There's no existing quality team, so you'll write the procedures, train the team on them, audit against them, and refine what doesn't work. What you'll do Own Design History Files and design control across multiple assay, consumable and instrument programs Lead ISO 14971 risk management, including hazard analysis, design/process/use FMEAs, and risk control verification Select, implement and administer the company's electronic QMS Run CAPA, nonconformance and deviation management end to end, from root cause to effectiveness checks Qualify and monitor suppliers, CDMOs and OEM partners, including incoming inspection and supplier corrective actions Lead process validation (IQ/OQ/PQ) and support assay, instrument and software validation Build the internal audit program and drive toward ISO 13485 certification and IVDR readiness What you'll bring 8-10+ years of quality experience within IVD product development and commercialization Experience building or substantially rebuilding a quality system, not just operating within one Ownership of a Design History File for at least one product from concept to design transfer or launch Working command of 21 CFR 820 (QMSR), ISO 13485, ISO 14971 and cGMP Strong applied statistics: sampling plans, process capability, gage R&R, method validation and DOE ASQ CQE certification or equivalent Enough technical depth in molecular, assay chemistry or instrumentation to credibly challenge data Bonus: IEC 62304 and premarket cybersecurity experience

🚨 Hiring: Clinical Research Associate (CRA), Medical Device | San Diego, CA 📍 Based fully onsite in San Diego CA with some domestic clinical site travel I'm partnering with a fast-moving, commercial stage medical device company running investigational device studies. The research here moves toward commercialization and patient impact rather than sitting in a lab for decades. What you'll do: Monitor multiple investigational device studies, both company-sponsored and investigator-initiated Run site qualification, initiation, interim monitoring and close-out visits Perform source data verification and manage queries, deviations and AE/device deficiency reporting Keep sites compliant with GCP, ISO 14155 and 21 CFR 812, and ready for inspection Serve as the primary sponsor contact for assigned sites What you'll need: Bachelor's degree in life sciences, nursing or a related field 2+ years in clinical research, including on-site monitoring (senior coordinators are welcome) Investigational device experience Hands-on experience with EDC, SDV and IRB/IDE documentation Self-starter who works independently under competing deadlines

Summary We have an immediate opening for a Senior Quality Specialist. This highly visible position is responsible for meeting and exceeding goals by advancing high-quality spinal fusion solutions utilizing cutting-edge implant technology. This role supports the operations organization with day-to-day, near-term, and long-term execution of quality tasks, requiring strong interpersonal skills and the ability to quickly meet supply chain requirements while supporting customer service, sales, engineering, and operations departments. Responsibilities Route, release, and control quality system documents Assign, monitor, and retain training records Maintain supplier qualification status Support the audit program and supplier quality activities Create and manage the CAPA and complaint program Lead nonconforming material investigations and segregation activities Support Quality Management Review Conduct DMR review for incoming and outgoing inspection Support development and maintenance of quality plans Requirements Bachelor's degree 3+ years of medical device experience Proficiency in Microsoft Office suite (Outlook, Excel, Word, PowerPoint, etc.) Ability to thrive in a startup environment Experience with an orthopedic medical device company or spine experience a plus ISO 13485 QMS auditor certificate

Summary We have an immediate opening for a Senior R&D Engineer. This highly visible position is responsible for the development and design of medical device instruments and implants, with quality and engineering development goals assigned to advance our high-quality spinal solutions using cutting-edge implant and instrument technology. This role requires strong mechanical design skills spanning brainstorming, design, prototyping support, DFM support, regulatory support, and product launch support, along with hands-on medical device design experience using SolidWorks and a solid understanding of medical device design controls. Responsibilities Lead design and development activities to release new product lines and maintain current ones Support marketing, quality, and regulatory departments as needed Mentor associate engineers and engineering interns as needed Requirements B.S. in Engineering, Mechanical or Biomechanical Minimum 5 years of related work experience (spine experience preferred) Proficiency in Microsoft Office suite (Outlook, Excel, Word, PowerPoint, etc.) Experience with an orthopedic medical device company or spine experience a plus Ability to multi-task and thrive in a startup environment 3+ years of experience with SolidWorks design software

Director of Procurement — Medical Device Location: Irvine, California or Remote Travel: Up to 30% Summary of Role We're a scaling medical device company seeking a Director of Procurement to lead our procurement team and provide strategic oversight of all sourcing, supplier management, and contract manufacturing (CMO) operations. This is an operationally focused leadership role responsible for stabilizing and maturing our procurement processes, strengthening supplier capabilities, and building a scalable global procurement strategy aligned with our commercialization goals and compliance requirements. Responsibilities Lead, mentor, and develop a team of six buyers across direct, indirect, and NPI procurement categories Strengthen sourcing strategies for components, materials, tooling, and services Own the full supplier lifecycle — selection, qualification, onboarding, and ongoing performance management Negotiate contracts, pricing, and commercial terms to achieve cost, quality, and risk-mitigation goals Serve as the primary operational interface for external manufacturing partners in Germany and other global regions Oversee capacity planning, production scheduling, and issue resolution with CMOs Support technology transfer, scale-up, and validation activities in collaboration with Engineering and Quality Establish and maintain supplier governance frameworks, KPIs, and performance review mechanisms Ensure supplier compliance with ISO 13485, EU MDR, FDA QSR, and internal quality requirements Lead supplier audits, corrective actions, and risk-mitigation initiatives Maintain supplier risk assessments and business continuity plans Partner cross-functionally with Engineering, Quality, Regulatory, and Finance to align procurement strategy with product development and commercialization milestones Support ERP, MRP, and master data initiatives related to suppliers, materials, and BOM accuracy Deliver regular reporting on procurement KPIs, supplier health, cost performance, and risk exposure Participate in and contribute to S&OP and broader company strategic goals Requirements Bachelor's degree in Supply Chain, Engineering, Business, or a related field 6–10 years of procurement and supplier management experience in MedTech, preferably with Class III Cardiovascular or Neurovascular experience Demonstrated experience managing CMOs and leading cross-functional sourcing initiatives Working knowledge of EU MDR, ISO 13485, and FDA QSR regulations Experience working in a startup or high-growth environment preferred Strong negotiation capabilities with a track record of managing complex supplier relationships preferred Proficiency with ERP systems, procurement tools, and data-driven decision-making preferred

Location: San Diego, CA (On-site) Summary We're seeking a Staff Engineer to serve as the primary technical owner of our next-generation medical device platform's electronics and firmware system — spanning board-level hardware, embedded firmware, and system integration. This is a hands-on, individual-contributor technical ownership role (not people management), where you'll be the central technical point of contact for our external electronics and firmware development partners, taking boards from design through bring-up, integration, and verification. Responsibilities Serve as the primary technical point of contact for external electronics and firmware development partners, reviewing and approving their schematics, PCB layouts, and firmware architecture Own board-level architecture decisions, board bring-up, debug, and validation using lab equipment (oscilloscopes, logic analyzers, multimeters) Own firmware and software architecture and technical roadmap, including driver, RTOS, connectivity, and UI integration work Own system integration end-to-end, diagnosing and resolving issues spanning the hardware/firmware boundary Define and track system-level integration and verification test plans with Quality Keep development activities aligned with Design Controls, IEC 62304, and IEC 60601 requirements Support technical investigations for field issues, NCRs, and CAPAs Requirements Bachelor's degree in Electrical Engineering, Computer Engineering, or related discipline (or equivalent practical experience) 8+ years of combined hardware and embedded firmware experience Demonstrated experience managing or coordinating the technical work of external development/contract engineering partners Strong embedded C experience, including RTOS (e.g., FreeRTOS) and MCU peripheral configuration (GPIO, ADC, timers, PWM, UART, SPI, I²C, DMA, interrupts) Experience with STM32 or comparable MCU platforms Proven ability to bring up, debug, and troubleshoot circuit boards using standard lab equipment Ability to read and review schematics and PCB layouts Medical device or other regulated product experience preferred Key Requirements Summary 8+ years combined hardware + embedded firmware experience Strong embedded C, RTOS (FreeRTOS), STM32/MCU peripheral work Board-level hardware: schematic/PCB review, bring-up, debug with lab equipment Experience managing external design firms/contract engineering partners Medical device/regulated industry experience strongly preferred (IEC 62304, IEC 60601)

We're looking for a Director of Clinical Research to own our clinical research organization — the data collection and scientific backbone of the company. You'll lead a team of 10+ research associates, data scientists, and data engineers, and serve as the senior physiological authority across every human research study powering our hardware, sensing, and AI/ML teams. You'll also own program management across the clinical team's full breadth — hardware studies, AI/ML development studies, and women's sleep studies — while acting as our public-facing voice on the science of sleep, from peer-reviewed publications to press and podcast appearances. This is a hands-on leadership role: you'll be as comfortable defining statistical criteria and reviewing raw data as you are managing people, budgets, and cross-functional stakeholders. What You'll Do Own the clinical research & science organization — lead, mentor, and grow a team of 10+ spanning clinical operations, data engineering, and data science Direct all human research studies supporting Hardware, Sensing, and AI/ML teams, from protocol development and study ideation through IRB submission, data collection, analysis, and reporting Uphold scientific validation standards by applying rigorous statistical and testing criteria (e.g., MAE, TOST equivalence testing, Bland-Altman analysis) to evaluate hardware and algorithm performance before launch Translate research into product features by partnering with Product, Growth, Design, and Engineering teams on science-backed features Provide scientific input on marketing claims, press releases, and journalist articles, ensuring every public-facing claim is backed by data Lead scientific communications — author and direct blog posts, white papers, and peer-reviewed publications, and represent the company in press interviews, podcasts, and conference talks Manage team growth and performance, including hiring, compensation strategy, mentorship, and formal performance management Drive new research exploration, identifying and pursuing external collaborations and new areas of sleep science Own budget and vendor management for clinical studies What You Bring PhD in physiology, neuroscience, sleep science, or a related field 10+ years of human research experience, including at least 5 years at high-growth startups or consumer health/hardware technology companies 5+ years of people management experience, including hiring, compensation decisions, and formal performance management Experience with biosensing devices or consumer health technology pursuing clinical validation Strong record of peer-reviewed publications; experience as author or Principal Investigator on IRB-approved clinical studies Advanced statistical fluency — able to define statistical criteria, run power calculations, and work directly with raw data alongside data scientists and biostatisticians Experience managing cross-functional programs spanning hardware validation, sensing, AI/ML, product, and marketing Excellent written and verbal communication skills across scientific and consumer audiences Hands-on, execution-oriented mindset, comfortable owning studies end-to-end in a fast-moving environment

Principal Optical Engineer | San Diego, CA (Onsite) We're hiring a Principal Optical Engineer to own the optical architecture of a next-generation DNA sequencing platform — from concept through commercialization. You'll drive the design, simulation, tolerancing, and characterization of a high-sensitivity optical detection system, partnering closely with cross-functional and external CRO/CDMO teams to bring a manufacturable product to market. What You'll Do Define optical architecture and technical strategy for high-throughput DNA sequencing platforms Lead end-to-end design, modeling, and optimization of illumination, imaging, and detection paths Perform optical design, ray tracing, tolerance analysis, and stray-light analysis in Zemax OpticStudio Build, align, test, and characterize optical prototypes and subsystems on the bench Define specs for custom optical components, coatings, and sources; own supplier drawings and acceptance criteria Partner with manufacturing contractors to transfer designs from prototype to volume production Lead the optical system through feasibility, design verification, design transfer, and commercial launch Collaborate with mechanical, electrical, software, and assay teams for full instrument integration What You Bring M.S. or Ph.D. in Optical Engineering, Optical Sciences, Physics, Electrical Engineering, or related field 10+ years of optical engineering/system design experience with multiple products commercialized Expert-level Zemax OpticStudio (sequential and non-sequential modeling, optimization, tolerancing) Hands-on bench experience with optical alignment, testing, and characterization Experience working with CRO/CDMOs and contract manufacturers on make-vs-buy and design transfer Deep knowledge of aberrations, diffraction, radiometry, polarization, and detector/sensor selection Preferred: experience with ultra-high-sensitivity detection (fluorescence, single-molecule, low-light imaging) and life science/genomics/diagnostics instruments Compensation & Benefits $175,000–$210,000/year (DOE) Medical, dental, vision; company-paid life insurance; 401(k); generous PTO

Position Overview Lead Quality Operations and the Quality Management System (QMS) for a San Diego manufacturing site, ensuring compliance with regulatory, customer, and business requirements. This role provides strategic and operational leadership across Quality Assurance and Quality Control, drives continuous improvement and risk management, and partners closely with site leadership to strengthen product quality, operational performance, and customer satisfaction. Reports to the Quality Director and works cross-functionally with Operations, Production, Engineering, Customer Service, and Sales. Responsibilities 🔹 Own the QMS and Quality Operations, ensuring compliance with regulatory, customer, and business requirements 🔹 Provide leadership, coaching, talent development, and performance management for QA/QC teams 🔹 Develop and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality 🔹 Establish quality objectives and KPIs aligned with business goals 🔹 Lead quality risk management across products, processes, suppliers, and quality systems throughout the product lifecycle 🔹 Ensure effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls 🔹 Lead Management Reviews and report quality performance, compliance, risks, and improvement initiatives to executive leadership 🔹 Direct internal, supplier, customer, certification, and regulatory audit programs, ensuring timely closure of findings 🔹 Ensure audit readiness and lead Quality representation during inspections 🔹 Establish and maintain a supplier quality management program, including qualification, monitoring, audits, and performance reviews 🔹 Promote a prevention-based quality culture through training, risk management, and continuous improvement initiatives Requirements ✅ Bachelor's degree in Engineering, Manufacturing, Quality, or a related field ✅ 5–7 years of experience in Engineering and/or Quality, preferably in medical device ✅ 3+ years in a supervisory or management role ✅ Experience with quality risk management principles in a regulated manufacturing environment ✅ Expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes ✅ Track record leading teams and driving continuous improvement in quality, compliance, and business performance ✅ Proficient in MS 365 applications ✅ Experience with ERP/MRP systems, electronic QMS (eQMS), and data analytics/reporting tools ✅ Comfortable working in both office and manufacturing environments, including occasional lifting up to 25 lbs

Senior Android Software Engineer — San Diego (On-site, Medical Device) A growing medical device company is looking for a Senior Android Engineer to join a small, tight-knit mobile team building software that's an integral part of a connected medical device ecosystem. This is a high-impact role at the intersection of mobile software, connected hardware, and patient care. What makes this role different: 🔹 100% native Android development in Kotlin — no cross-platform frameworks 🔹 You'll own complex features end-to-end — design through implementation, verification, release, and post-market support 🔹 Work directly with embedded, cloud, systems, cybersecurity, and regulatory teams 🔹 BLE and connected-hardware experience is a big plus 🔹 Open to Sr. SWE or Technical Lead level, depending on background — room to grow into a leadership track What they're looking for: ✅ 7+ years professional software development, strong Android focus ✅ Advanced Kotlin, Jetpack Compose, Coroutines/Flow, modern Android architecture ✅ Experience building apps that run reliably in the background — handling connectivity drops, OS restrictions, device restarts ✅ A genuine Android enthusiast — someone who's plugged into the platform and excited by new OS releases ✅ You've personally shipped an app to the Play Store ✅ Medical device, digital health, or other highly regulated industry background (DoD, etc. also considered) ✅ Strong ownership mentality — you build it right the first time Details: 📍 San Diego, CA — on-site, hybrid Tues–Thurs in office 💰 Competitive base + RSUs + bonus 🚫 No visa sponsorship available

Director of Clinical Affairs Can be based in San Francisco, CA or Boston, MA We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on, operationally intense role for someone who has taken devices or SaMD from earliest-stage concept all the way through trial completion and into post-market surveillance — not just a single phase of the lifecycle. What You'll Do Own the full device/SaMD clinical lifecycle — from early-stage study design through trial execution, final study report, and post-market surveillance Develop study design from scratch in close collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees Lead clinical study execution — feasibility, site selection, activation, enrollment, monitoring, and close-out Write and manage IRB/Ethics submissions, informed consent forms, and study essential documents Select, qualify, and oversee third-party clinical sites and investigators as primary point of contact Manage clinical data operations — eCRF design, data review, query resolution, vendor coordination Develop study timelines, budgets, and risk mitigation plans, reporting clearly to leadership Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance Manage CRO and clinical vendor relationships, including contract negotiation and performance oversight Collaborate cross-functionally with regulatory, product, engineering, and legal teams Support RA/QA peers on FDA interactions, pre-subs, and 510(k) submissions Build and scale the clinical operations function — SOPs, templates, and tracking systems Maintain post-market surveillance activities, including adverse event monitoring and reporting What You Bring Minimum B.S. Degree with 10+ years hands-on clinical operations experience (5+ in leadership) running trials for FDA-regulated medical devices, SaMD/digital health, or combination products Demonstrated experience owning a device or SaMD through the complete lifecycle — from initial concept and study design through trial completion and post-market surveillance Track record of building study designs from scratch alongside key internal and external stakeholders Experience with biosensing devices, consumer health tech, or wellness platforms pursuing clinical validation Familiarity with RWE study designs and decentralized/hybrid trial models Startup or scale-up experience building processes from scratch Experience supporting breakthrough device designations or pre-sub meetings Experience launching studies across multiple regions/countries, with direct exposure to varying regulatory bodies and government requirements Track record of trials leading to FDA clearances/approvals or labeling expansions Experience managing third-party clinical sites end-to-end (selection through close-out) Proven ability authoring IRB/Ethics submissions, ICFs, and clinical protocols 7+ years cross-functional program management across clinical, engineering, and regulatory Strong clinical data management knowledge (eCRF, data cleaning, query management, database lock) Fluency in FDA device regulations (IDE, De Novo, 510(k)), ICH-GCP, ISO 14155, and SaMD guidance Experience with study budgeting, vendor management, and CRO oversight KOL relationship-building experience

Senior Director, Regulatory Affairs (fully on-site in San Diego) Summary Our client is a well-funded, growth-stage medical technology company developing a Class III active implantable platform at the intersection of healthcare and advanced engineering. This role serves as the senior regulatory leader for the company's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. The Senior Director will own regulatory strategy for new platform development, oversee ongoing product updates and manufacturing-related submissions, and work closely with engineering, quality, and clinical teams to ensure regulatory readiness throughout the product lifecycle. Responsibilities Lead regulatory strategy and submission planning for software, firmware, and hardware across new product development programs and product updates Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed Develop and execute software and firmware regulatory strategy for complex implantable devices, including AI/ML considerations, change management, and lifecycle documentation Provide regulatory support for manufacturing-related activities, including process changes and design transfers Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization Provide regulatory guidance on new product concepts, design inputs, and technology transfers Support project planning and roadmaps with well-defined regulatory milestones and risk assessments Monitor evolving FDA regulations, guidance, and international standards relevant to Class III implantable devices and complex software/firmware-driven medical technologies Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations Represent the company in FDA meetings, pre-submission interactions, and agency correspondence Minimal travel expected ( Requirements Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred 12+ years of regulatory affairs experience in the medical device industry, including demonstrated experience with complex Class II or III Medical Devices. Strong software and firmware regulatory expertise, including AI/ML-enabled features and applicable FDA guidance Track record of independently leading FDA submissions (IDE, PMA, supplements) and managing agency interactions Familiarity with manufacturing-related regulatory considerations (process changes, design transfers) in a device development or scale-up context Experience supporting new product development from concept through submission, including design control and risk management Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards Exceptional written and verbal communication skills; able to translate regulatory complexity for engineering and executive audiences Comfortable operating in a lean, startup-style environment Preferred : RAC certification (RAPS); experience with implantable neurotechnology or neural stimulation devices; familiarity with OUS pathways (CE Mark, TGA); experience scaling a regulatory function at a growth-stage company.

Product Manager (Senior Staff/Associate Director Level) Hybrid on-site in San Diego, CA About the Role A San Diego-based biotech developing next-generation genomics platforms to transform genetic testing and sequencing is hiring a Product Manager to own the product strategy and commercialization of their target detection platform. This is a hybrid product-and-marketing role: you will translate customer and clinical insight into product requirements and roadmap, build the business case and competitive positioning, and drive go-to-market strategy, launch, and post-launch performance — partnering with engineering, assay, regulatory, and software teams across RUO, LDT, and IVD development phases. Key Responsibilities Own product strategy and roadmap for the company's target detection platform, translating VOC from clinicians, lab directors, and KOLs into prioritized product requirements Partner with engineering, assay development, integration, software, regulatory, and operations to balance clinical value, technical feasibility, and time-to-market Develop product positioning, messaging, and value propositions for clinical, laboratory, and economic buyers — including health-economic and clinical-utility narratives Build business cases and financial models (market sizing, segmentation, ROI) to support executive go/no-go decisions Conduct competitive analysis across sepsis, pathogen identification, and AMR detection to identify differentiation and white-space opportunities Drive GTM strategy with commercial, sales, and marketing leadership — including pricing, channel, and launch-readiness planning Lead product launches end-to-end: sales enablement, collateral, training, KOL engagement, adoption tracking, and post-launch performance Collaborate with regulatory and quality teams to ensure product requirements and commercial materials are compliant in a regulated diagnostics environment Define and track product and commercial success metrics to inform roadmap prioritization Required Qualifications Bachelor's degree in life sciences, biomedical engineering, business, or a related discipline with 8+ years of relevant PM and/or product marketing experience in diagnostics or life sciences. MBA or advanced degree preferred. Demonstrated PM and/or product marketing experience in diagnostics, life sciences, or medical devices — with a track record of bringing products from concept through commercialization Hands-on IVD and LDT development experience, including familiarity with the requirements they impose on product and commercial activities Proven ability to translate VOC and clinical insight into prioritized, actionable product requirements Track record building business cases, financial models, and competitive analyses to inform executive decision-making Experience defining and executing GTM strategy, including positioning, messaging, and value proposition development Strong cross-functional leadership and communication skills across R&D, regulatory, clinical, commercial, and executive stakeholders Self-directed and ownership-oriented — comfortable operating with significant autonomy in an early-stage, evolving environment Preferred Qualifications Direct experience in molecular diagnostics, ideally in sepsis and/or pathogen identification Familiarity with clinical microbiology and infectious disease testing landscapes, workflows, and buyer dynamics Experience developing clinical-utility content, health-economic/ROI models, and KOL and clinical-evidence strategy Experience at an early-stage or scaling diagnostics company balancing near-term delivery against long-term platform strategy Why Join Us Work on cutting-edge genomics and molecular detection technologies Shape the commercial strategy of a differentiated diagnostic platform from the ground up Collaborate with a deeply technical, cross-functional team High visibility and direct impact on product, commercial, and strategic decisions at an early stage