Position Details
About this role
The role involves ensuring the safety, effectiveness, and compliance of high-risk medical devices through design verification, validation, and risk management activities.
Key Responsibilities
- Drive and document Design Verification and Validation activities
- Apply data-driven problem solving
- Partner with cross-functional teams
- Develop and maintain DHF and risk management artifacts
- Support regulatory submissions
Technical Overview
Focuses on design assurance for medical devices, including design controls, risk management, and regulatory documentation, within a hybrid work environment.
Ideal Candidate
The ideal candidate is a mid-level biomedical engineer with experience in design assurance, risk management, and regulatory compliance within medical device development. They should have a strong understanding of design controls and validation processes to ensure product safety and effectiveness.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with medical device regulations, No Bachelor's degree in Engineering or related field, Unfamiliarity with design controls and risk management
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