Medical Device Design Control Engineer

About the Role:

We are seeking an experienced Medical Device Design Control and Risk Management Contractor to support quality, regulatory, and product development initiatives in the molecular diagnostics space. The ideal candidate will bring deep expertise in design controls, risk management, and GMP in Next Generation Sequencing (NGS) field. This role will collaborate closely with cross-functional teams to ensure that NGS-based products and workflows meet regulatory, quality, and performance standards.

Minimum Qualifications:

• Bachelor's or Master's degree in Molecular Biology, Biomedical Engineering, Genetics, or related field.
• 5+ years of industry experience, including hands-on experience in NGS testing, sequencing workflow development, or molecular diagnostics.
• Proven expertise in design controls, risk management, ISO 14971, GMP, ISO 13485, and FDA regulatory frameworks.
• Experience with Illumina, ThermoFisher, or other NGS platforms; knowledge of bioinformatics workflows is a plus.
• Familiarity with oncology, liquid biopsy, ctDNA, or other clinical sequencing applications (preferred).
• Strong documentation, communication, and cross-functional coordination skills.

Preferred Qualifications:

• Advanced degree or certification in Quality Assurance, Regulatory Affairs, or a related discipline.
• Experience with risk management standards such as ISO 14971.
• Familiarity with software tools used for design control documentation and project management.
• Previous experience working in a research and development or automation environment within the medical device industry.
• Demonstrated ability to lead design control audits and regulatory inspections.

Responsibilities:

Design Controls

• Develop, maintain, and optimize design control documentation including User Needs, Design Inputs, Design Outputs, Verification/Validation plans, and Design History Files (DHF) for NGS-based products or assays.
• Support Design Reviews and design transfer activities for NGS workflows and instrumentation.
• Establish traceability matrices linking requirements, risks, sequencing workflow steps, and V&V activities.

Risk Management

• Lead and facilitate risk management activities per ISO 14971, including hazard analyses, FMEAs (DFMEA, PFMEA), and risk control strategy development.
• Maintain and update Risk Management Files (RMF) throughout product lifecycle.
• Provide subject-matter expertise in risk evaluation, benefit-risk analysis, and post-market risk assessment.

GMP & Quality Systems Support

• Ensure alignment of design and development processes with GMP, QSR, and ISO 13485 requirements.
• Review and improve SOPs, work instructions, and product documentation to strengthen compliance.
• Conduct gap assessments and recommend corrective/preventive actions (CAPA) for design or process-related issues.
• Support audits (internal/external), including preparation of evidence and remediation activities.

Cross-Functional Collaboration

• Work closely with R&D, Quality Assurance, Regulatory Affairs, and Operations to ensure smooth development pathways.
• Provide training or guidance on design control and risk management best practices.

Skills:

The Medical Device Design Control Specialist utilizes their expertise in regulatory standards and quality systems to ensure that all design activities comply with applicable laws and guidelines. Strong organizational skills are essential for managing complex documentation and maintaining traceability throughout the product lifecycle. Effective communication skills enable the specialist to work collaboratively with engineers, quality professionals, and regulatory personnel to resolve design control issues and facilitate smooth product development. Analytical skills are applied to assess risks, review design outputs, and verify that validation activities meet predetermined criteria. Additionally, proficiency with relevant software tools supports efficient documentation management and process tracking, contributing to continuous improvement in design control practices.

Contract Details:
• Contract Type: Temporary
• Duration: 6-12 months (flexible based on project needs) with extension or permanent hiring potential
• Commitment: Full-time
• Location: Onsite, Hayward, CA

We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.