Position Details
About this role
This role leads design assurance efforts for a critical electrophysiology medical device platform, ensuring compliance, robustness, and safety through risk management and validation activities.
Key Responsibilities
- Lead design control activities
- Manage risk and hazard analysis
- Oversee design verification and validation
- Maintain risk management files
- Collaborate with R&D, regulatory, and manufacturing teams
Technical Overview
Focuses on design control, risk management, and software validation for medical devices, with standards like IEC 62304 and ISO 13485, involving cross-functional collaboration.
Ideal Candidate
The ideal candidate is a senior quality engineer with extensive experience in design assurance, risk management, and regulatory compliance within medical device development, particularly in electrophysiology systems. They possess strong leadership skills and are capable of mentoring junior engineers.
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 IEC 62304 or ISO 13485, No background in medical device quality assurance, Unwillingness to work in a hybrid onsite environment, No experience with electrophysiology or related medical devices
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