Position Details
About this role
This role involves supporting the development and maintenance of software for implantable medical devices, ensuring compliance with safety standards, risk management, and verification processes.
Key Responsibilities
- Implement software design assurance
- Manage risk per ISO 14971
- Conduct software V&V
- Support regulatory compliance
- Collaborate with cross-functional teams
Technical Overview
The environment includes software design assurance, risk management per ISO 14971, software V&V, and regulatory standards for medical devices, supporting cross-functional teams in product development.
Ideal Candidate
The ideal candidate is a quality engineer with experience in software design assurance, risk management (ISO 14971), and validation processes within medical device development, preferably with knowledge of implantable devices and regulatory standards.
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 software, No knowledge of ISO 14971, No experience in cross-functional teams
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