Eliassen Group

Description

Senior Quality R&D Design Engineer - Design Controls, Risk Management

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.

They are seeking a Sr. R&D Engineer - Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.

DUTIES / EXPECTATIONS OF THIS ROLE

• 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.

MUST HAVES - QUALIFICATION SUMMARY

• 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.

NICE-TO-HAVES

• Familiarity with CAD software and testing tools a plus.

TRAVEL & LOCATION

Onsite in Redwood City, CA with flexibility to work in a hybrid capacity.

Domestic and international travel (less than 20%) to collaborate with external vendors and support clinical trials when necessary.

START & TERM ASAP, 6-month contract-to-hire

CONSULTING RATE: Competitive