Ecocareers · 2 months ago
Senior Quality R&D Design Engineer
Redwood, CA
Full-time
Hybrid
Senior Level
5+ years expConfidential company is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies. They are seeking a Sr. R&D Engineer – Design Controls & Risk Management to support ongoing development programs, focusing on ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle.
Staffing & Recruiting
Responsibilities
Prepare and present structured technical documentation and summaries for internal and external stakeholders
Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports
Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software)
Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities
Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment
Participate in and/or lead formal design reviews, risk reviews, and test planning sessions
Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations
Support updates to design control and risk documentation during design changes, sustaining engineering, or complaint investigations
Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971
Drive continuous improvement of design control and risk management processes to enhance efficiency and compliance
Qualification
Required
Bachelor's or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience)
5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred)
Proven experience authoring and managing requirements, traceability matrix, and risk documentation
Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971
Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies
Strong attention to detail with a systematic approach to documentation and traceability
Excellent organizational and communication skills with the ability to manage multiple priorities
Preferred
Familiarity with CAD software and testing tools a plus
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase