Job Title: IT Contractor - ERP System Specialist (Medical Device Startup)

Location: Remote or Hybrid in Orange County

Contract Type: 6-weeks to start. Possibility for extension. 

About Us:

We are a fast-growing medical device startup dedicated to [briefly describe what the company does, e.g., "revolutionizing patient care through innovative diagnostic tools," "developing next-generation surgical implants"]. As we scale our operations, we recognize the critical need for a robust and integrated ERP system to streamline our processes and ensure compliance within the highly regulated medical device industry.

The Opportunity:

We are seeking an experienced and highly motivated IT Contractor to lead our ERP system selection and implementation journey. This individual will play a pivotal role in guiding our company through the complex process of identifying, evaluating, and ultimately deploying an ERP solution that seamlessly integrates with our existing Quality Management System (QMS), Product Lifecycle Management (PLM), financial, and sales functions.

Key Responsibilities:

• ERP Needs Assessment & Requirements Gathering:

  • Collaborate with key stakeholders across QMS, PLM, Finance, Sales, Operations, and Engineering to thoroughly understand current processes, pain points, and future requirements.

  • Document detailed functional and technical specifications for the ideal ERP system, specifically considering the unique needs and regulatory requirements of a medical device company (e.g., UDI, traceability, regulatory reporting).

• ERP System Research & Evaluation:

  • Conduct comprehensive market research to identify potential ERP vendors and solutions suitable for a medical device startup.

  • Evaluate shortlisted ERP systems based on established criteria, including functionality, scalability, integration capabilities, vendor reputation, cost-effectiveness, and compliance features (e.g., 21 CFR Part 11).

  • Facilitate vendor demonstrations and technical deep-dives to assess system capabilities.

• ERP System Selection & Recommendation:

  • Develop a clear recommendation for the optimal ERP system, including a detailed justification, cost-benefit analysis, and proposed implementation roadmap.

  • Present findings and recommendations to senior leadership for decision-making.

• Implementation Planning & Management:

  • Develop a comprehensive project plan for the ERP implementation, including scope, timelines, resource allocation, and risk management.

  • Serve as the primary liaison between internal teams and the selected ERP vendor during the implementation phase.

  • Coordinate and oversee data migration, system configuration, user acceptance testing (UAT), and go-live activities.

• Integration & Workflow Optimization:

  • Work closely with functional leads to ensure seamless integration between the new ERP system and existing critical systems (QMS, PLM, financial software, CRM/sales tools).

  • Identify opportunities for process optimization and workflow automation enabled by the new ERP system.

• Training & Change Management Support:

  • Assist in the development and delivery of training materials and sessions for end-users.

  • Support change management efforts to ensure a smooth transition and user adoption of the new system.

• Documentation & Reporting:

  • Maintain detailed documentation of system configurations, integrations, and processes.

  • Provide regular progress updates and status reports to stakeholders.

Required Qualifications:

• Bachelor's degree in Information Technology, Computer Science, Business Administration, or a related field.

• [Minimum number] years of experience in ERP system selection, implementation, and integration, with a strong preference for experience within the medical device or other highly regulated manufacturing industries.

• Proven track record of successfully managing complex IT projects from inception to completion.

• Deep understanding of common ERP modules and functionalities (e.g., manufacturing, supply chain, inventory, finance, quality, sales).

• Experience with and understanding of integrating ERP systems with:

  • Quality Management Systems (QMS): (e.g., ISO 13485, FDA 21 CFR Part 820 requirements, CAPA, document control)

  • Product Lifecycle Management (PLM) systems: (e.g., BOM management, change control)

  • Financial systems: (e.g., general ledger, accounts payable/receivable)

  • Sales and CRM functions.

• Strong analytical and problem-solving skills with a meticulous attention to detail.

• Excellent communication, interpersonal, and presentation skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.

• Self-motivated, proactive, and able to work independently with minimal supervision.

Preferred Qualifications:

• Certification in a recognized ERP system (e.g., SAP, Oracle, NetSuite, Microsoft Dynamics, Plex, Epicor) relevant to the medical device industry.

• Experience with validation processes for GxP systems.

• Familiarity with data privacy regulations (e.g., GDPR, HIPAA).

Job Title: IT Contractor - ERP System Specialist (Medical Device Startup)

Location: Remote or Hybrid in Orange County

Contract Type: 6-weeks to start. Possibility for extension. 

About Us:

We are a fast-growing medical device startup dedicated to [briefly describe what the company does, e.g., "revolutionizing patient care through innovative diagnostic tools," "developing next-generation surgical implants"]. As we scale our operations, we recognize the critical need for a robust and integrated ERP system to streamline our processes and ensure compliance within the highly regulated medical device industry.

The Opportunity:

We are seeking an experienced and highly motivated IT Contractor to lead our ERP system selection and implementation journey. This individual will play a pivotal role in guiding our company through the complex process of identifying, evaluating, and ultimately deploying an ERP solution that seamlessly integrates with our existing Quality Management System (QMS), Product Lifecycle Management (PLM), financial, and sales functions.

Key Responsibilities:

• ERP Needs Assessment & Requirements Gathering:

  • Collaborate with key stakeholders across QMS, PLM, Finance, Sales, Operations, and Engineering to thoroughly understand current processes, pain points, and future requirements.

  • Document detailed functional and technical specifications for the ideal ERP system, specifically considering the unique needs and regulatory requirements of a medical device company (e.g., UDI, traceability, regulatory reporting).

• ERP System Research & Evaluation:

  • Conduct comprehensive market research to identify potential ERP vendors and solutions suitable for a medical device startup.

  • Evaluate shortlisted ERP systems based on established criteria, including functionality, scalability, integration capabilities, vendor reputation, cost-effectiveness, and compliance features (e.g., 21 CFR Part 11).

  • Facilitate vendor demonstrations and technical deep-dives to assess system capabilities.

• ERP System Selection & Recommendation:

  • Develop a clear recommendation for the optimal ERP system, including a detailed justification, cost-benefit analysis, and proposed implementation roadmap.

  • Present findings and recommendations to senior leadership for decision-making.

• Implementation Planning & Management:

  • Develop a comprehensive project plan for the ERP implementation, including scope, timelines, resource allocation, and risk management.

  • Serve as the primary liaison between internal teams and the selected ERP vendor during the implementation phase.

  • Coordinate and oversee data migration, system configuration, user acceptance testing (UAT), and go-live activities.

• Integration & Workflow Optimization:

  • Work closely with functional leads to ensure seamless integration between the new ERP system and existing critical systems (QMS, PLM, financial software, CRM/sales tools).

  • Identify opportunities for process optimization and workflow automation enabled by the new ERP system.

• Training & Change Management Support:

  • Assist in the development and delivery of training materials and sessions for end-users.

  • Support change management efforts to ensure a smooth transition and user adoption of the new system.

• Documentation & Reporting:

  • Maintain detailed documentation of system configurations, integrations, and processes.

  • Provide regular progress updates and status reports to stakeholders.

Required Qualifications:

• Bachelor's degree in Information Technology, Computer Science, Business Administration, or a related field.

• [Minimum number] years of experience in ERP system selection, implementation, and integration, with a strong preference for experience within the medical device or other highly regulated manufacturing industries.

• Proven track record of successfully managing complex IT projects from inception to completion.

• Deep understanding of common ERP modules and functionalities (e.g., manufacturing, supply chain, inventory, finance, quality, sales).

• Experience with and understanding of integrating ERP systems with:

  • Quality Management Systems (QMS): (e.g., ISO 13485, FDA 21 CFR Part 820 requirements, CAPA, document control)

  • Product Lifecycle Management (PLM) systems: (e.g., BOM management, change control)

  • Financial systems: (e.g., general ledger, accounts payable/receivable)

  • Sales and CRM functions.

• Strong analytical and problem-solving skills with a meticulous attention to detail.

• Excellent communication, interpersonal, and presentation skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.

• Self-motivated, proactive, and able to work independently with minimal supervision.

Preferred Qualifications:

• Certification in a recognized ERP system (e.g., SAP, Oracle, NetSuite, Microsoft Dynamics, Plex, Epicor) relevant to the medical device industry.

• Experience with validation processes for GxP systems.

• Familiarity with data privacy regulations (e.g., GDPR, HIPAA).