Melody Lam

Staff / Senior Staff Sustaining Engineer | Medical Devices I’m partnering with a commercial-stage medical device company to hire a Staff or Senior Staff Sustaining Engineer. You’ll be the technical lead keeping a commercial disposable device line reliable, manufacturable and performing well in the field. THE ROLE You’ll own complex product issues end to end: complaints, CAPAs, field problems, supplier and material changes, and manufacturing issues. You’ll lead each one from root cause through closure, working across Quality, Manufacturing, Regulatory, Supply Chain and R&D. The environment moves fast and priorities can shift quickly, so you’ll need to be comfortable reprioritizing while keeping ownership. RESPONSIBILITIES Lead sustaining engineering for commercial products Investigate and resolve complaints, field issues, manufacturing problems and customer escalations Lead CAPA, root-cause analysis, corrective actions and effectiveness checks Evaluate and implement material, component, supplier and process changes, including risk assessment and V&V Drive biocompatibility, sterility and sterile barrier testing, coordinating with external test labs Perform design verification, design validation and process validation, and prepare documentation for regulatory submissions Analyze complaint, manufacturing and field data to spot trends early Support product improvements, cost reductions, supply continuity and obsolescence management Maintain specifications, drawings, risk files and test methods Mentor engineers and guide cross-functional teams QUALIFICATIONS BS or higher in Mechanical, Biomedical, Materials, Manufacturing or related engineering 8+ years of experience for Staff, 10+ for Senior Staff Broad sustaining, product, manufacturing or quality engineering experience on commercial products Strong track record with CAPA, root-cause investigations, complaints and field issues Experience implementing material, supplier or process changes Proven ability to lead cross-functional issues to closure Experience in a regulated development or manufacturing environment PREFERRED Disposable or single-use medical device experience ISO 13485, FDA QSR, design controls and risk management Polymers, adhesives, molded components, assemblies or packaging Product or mechanical design background Statistical methods and data analysis

ASIC Technical Lead | Neurotech / BCI | San Diego, CA (Onsite) I’m partnering with a venture-backed neurotechnology company developing an implantable brain-computer interface for people with severe paralysis. The company is in clinical trials and is now scaling a San Diego R&D team to build its next-generation platform. They need an experienced ASIC engineer to serve as the technical owner of a custom neural recording chip. A specialist IC design firm handles the design execution. This person is the company’s in-house expert who makes sure the chip is right. WHAT THE JOB IS You won’t be designing the chip yourself. You’ll define what it needs to do, scrutinize the partner’s work at every stage, and decide when it’s ready for fabrication. When silicon comes back, you’ll lead the effort to confirm it performs as intended and get to the bottom of anything that doesn’t. RESPONSIBILITIES Write and maintain the chip requirements and specification, with full traceability Lead technical reviews with the design partner from architecture through final sign-off, digging into the underlying schematics and simulation data Evaluate simulation, physical verification and design-for-test work, and own the decision to proceed to fabrication Identify and manage technical risks such as noise, power, matching and process variation across a large channel count Work with the in-house test engineer on silicon bring-up and characterization, and lead debug when issues come up Drive any required design revisions and the plan to re-verify them Support the chip through qualification and production, and define requirements for future generations QUALIFICATIONS BS or MS in Electrical Engineering or related field, with a focus on IC design 5+ years of ASIC or SoC experience, including at least one chip taken from concept through silicon An analog or mixed-signal IC design or verification background Experience reviewing simulation results (SPICE/Cadence), physical verification (DRC/LVS) and DFT Experience managing an outside design partner, foundry or fab Bonus: medical device experience (design controls, FDA submissions) or implantable electronics WHY CONSIDER IT Early role on a next-generation BCI program High-impact technical ownership of a novel neural recording chip A growing San Diego team working on technology that restores function for patients

Senior R&D Electrical Engineer – San Diego, CA I’m hiring a Senior R&D Electrical Engineer for an implantable neurotechnology company developing next-generation implantable electronics. This is a hands-on, technically deep role owning the electrical and programmable-logic design of the implant from concept through design verification. What You’ll Do Architect and develop synthesizable HDL (VHDL or SystemVerilog) for a low-power FPGA serving as the implant’s health, status, control, and communications controller Implement supervisory functions: power sequencing, voltage/current/temperature monitoring, watchdogs, fault detection, and safe-state transitions Define and implement the implant side of a high-speed serial link to distributed sensing electronics, proven in FPGA emulation with silicon partners ahead of hardware Design fault-tolerant control and monitoring logic, including redundant monitors, independent shutdown paths, and fail-safe defaults; lead FMEA and fault-tree analysis per ISO 14971 Own the implant’s electrical architecture, including custom silicon integration, inductive charging, RF telemetry, and power budgeting Lead miniaturized PCB and flex-rigid design in Altium Define and execute electrical and FPGA verification plans within design controls (IEC 60601-1, IEC 62304, ISO 14708) Review and debug firmware and test software alongside the firmware team; support design transfer to contract manufacturers What You Bring BS in Electrical Engineering, Computer Engineering, or related field 8+ years in mixed-signal hardware design for miniaturized, high-reliability electronic systems 5+ years of hands-on FPGA development on low-power families, including timing closure, clock-domain crossing, and simulation-based verification Serial interface design experience: LVDS/CML signaling, source-synchronous or CDR schemes, framing and error detection, SPI/I2C, register maps Design of safety-relevant or fault-tolerant digital systems Hands-on inductive power transfer or resonant/magnetics design High-density PCB and flex design in Altium; SPICE and signal-integrity analysis Ability to read, debug, and review embedded C firmware Experience taking electronic subsystems from prototype through design verification into production Nice to Have Active implantable device experience (neurostimulators, cochlear implants, cardiac rhythm devices) Custom silicon co-design and FPGA emulation of partner RTL Functional safety standards (IEC 60601-1 PEMS, IEC 61508, ISO 26262, DO-254) Implantable or body-worn antenna/RF design with EM simulation (HFSS, CST, COMSOL) Coil design and EM/thermal modeling, including MRI compatibility Low-noise neural or bioelectric front-end design Experience supporting IDE, PMA, or 510(k) submissions

Staff/Principal Mechanical Engineer – Medical Device Startup | San Diego, CA (Onsite) I’m partnering with a venture-backed medical device startup in San Diego developing a wearable automated insulin delivery system that makes life with diabetes simpler and safer. Their product has reached clinical studies, and they’re now hiring a Staff/Principal Mechanical Engineer to carry the hardware system through verification and into volume manufacturing. The Role You’ll be the hub of the hardware design: the system integrator who brings together user needs, risk analysis, mechanics, electronics, and industrial design into one cohesive product, while staying hands-on in detailed design, analysis, and debugging. What You’ll Do Integrate mechanisms, electronics, motion, fluidics, and packaging into a cohesive, user-centered product Translate user needs into design requirements, partnering with industrial design Lead risk analysis to drive design decisions and mitigations from the earliest stages Own electronics integration within the mechanical system alongside electrical engineering Design molded and machined assemblies using tolerance analysis as a core design tool Partner with regulatory, quality, and manufacturing on design controls, V&V, biocompatibility, sterilization, human factors, and design transfer Coordinate projects, timelines, and budgets; mentor junior engineers as the team grows What You Bring BS in Mechanical Engineering or related field (MS a plus) 8+ years of mechanical product design experience, including medical devices or other safety-critical systems Track record taking a product from design through verification into volume manufacturing Experience as the technical integrator across mechanical, electrical, industrial design, and user requirements Experience designing mechanisms and moving assemblies, ideally compact motorized electromechanical devices Deep hands-on expertise with molded and machined parts and advanced tolerance analysis Working knowledge of design controls, V&V, risk analysis, biocompatibility, sterilization, and human factors

Director of Software (San Diego, CA — On-site) An innovative medical device company at a growth inflection point — with a product already in clinical studies — is seeking a Director of Software to lead and scale their software organization. This is a builder's leadership role reporting to the VP of R&D, combining hands-on technical depth with people leadership as the team grows from lean and high-performing into full commercial scale. What you'll own: Build and scale the software team — hiring, mentoring, and establishing a culture where engineers do their best work Drive engineering effectiveness — coding standards, workflows, and AI-enabled acceleration Translate executive vision into actionable technical strategy and roadmaps Stay technically hands-on — prototype, review, and build alongside the team Represent software cross-functionally with hardware, data science, regulatory, and executive stakeholders Own team budget, resource allocation, and delivery timelines What we're looking for: Bachelor's degree in Computer Science, Software Engineering, or related field 10–15+ years in software development, including 5+ years managing technical teams Experience shipping mobile apps and cloud backends end-to-end, ideally for a connected-device fleet Regulated industry experience — medical device or other safety-critical software strongly preferred Fluency in modern DevOps, CI/CD, and automation testing Comfort applying AI tools safely and effectively within a regulated environment 📍 Must be local to or willing to relocate immediately to San Diego, CA — this is an on-site role.

Sr. Process Development Engineer, Catheter Engineering San Francisco Bay Area (East Bay), onsite | Full-time Position Summary An innovative medical device company is hiring a Sr. Process Development Engineer to help bring its next-generation catheter technology to market. This role bridges early-stage development and commercial manufacturing: you’ll take early clinical catheter devices and refine them into robust, manufacturable products ready for launch. It’s ideal for someone with deep catheter engineering expertise, a manufacturing mindset, and a track record of successful design transfer. Responsibilities Lead process development to move catheter devices from first-in-human configurations to scalable commercial products Perform DFM/DFA analyses and tolerance stack-ups (worst-case and statistical), and define critical dimensions and component acceptance criteria Develop component specifications, drawing requirements, and incoming inspection criteria, including AQL sampling plans Characterize and optimize catheter processes: extrusion, braiding, tip forming, thermal bonding, adhesive joining, and laser cutting Develop electrical assembly processes for catheter-integrated components, including fine-gauge wire termination, surface-mount placement, and high- and low-voltage cable assembly Partner with Manufacturing Engineering on process validation (IQ/OQ/PQ), pFMEAs, SPC, capability studies (Cp/Cpk), and yield targets Develop inspection gauges and conduct MSA and gauge R&R studies Evaluate and qualify materials, adhesives, and components for processability and biocompatibility Manage ECOs while maintaining design history file integrity Ensure compatibility with sterilization methods (EO, gamma, e-beam) and packaging requirements Apply Lean principles to reduce waste and cycle time for commercial scale-up Partner with suppliers and contract manufacturers on process capability and continuous improvement Create work instructions, assembly procedures, and process travelers for design transfer Mentor junior engineers and technicians on problem solving and root cause analysis Requirements BS in Mechanical, Biomedical, Materials Science, or Manufacturing Engineering, or a related field; MS preferred 5+ years of medical device process development or manufacturing engineering experience, including 3+ years on catheter-based devices Proven experience taking a device from early-stage development to commercial manufacturing Hands-on catheter manufacturing experience: extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser processing Proficiency in tolerance stack-up analysis and statistical methods (Cp/Cpk, SPC, gauge R&R); DOE a plus Experience supporting IQ/OQ/PQ in a regulated environment Familiarity with 21 CFR 820, ISO 13485, and ISO 14971 SolidWorks and GD&T (ASME Y14.5); Minitab preferred Working knowledge of catheter materials: PEBAX, nylon, polyurethane, PTFE, nitinol, stainless steel, platinum-iridium, and adhesive systems Root cause analysis tools: FMEA, fishbone, 8D, 5 Whys Cleanroom experience (ISO Class 7/8) preferred Strong project management and communication skills Up to 15% travel for supplier and contract manufacturer activities Compensation and Location Base salary of $130K–$155K, plus stock options and ESPP Onsite in the East Bay. Candidates must live in the SF Bay Area; relocation isn’t offered.

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

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)

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