Position Details
About this role
This role involves supporting new product development and sustaining activities for cardiac mapping and ablation systems, ensuring safety, quality, and regulatory compliance in a medical device environment.
Key Responsibilities
- Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing
- Leads/supports the determination and implementation of Design Controls
- Maintains product risk management documentation
- Leads/supports development of Design Validation and Verification activities
- Supports and leads CAPA investigations
Technical Overview
The position requires expertise in design controls, risk management, validation and verification processes, and familiarity with medical device standards and regulatory requirements.
Ideal Candidate
The ideal candidate is a mid-level Design Assurance Engineer with at least 4 years of experience in medical device quality and design assurance. They possess strong knowledge of risk management, validation, and regulatory standards, and are capable of working cross-functionally to ensure product safety and compliance.
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 in medical device industry, No Bachelor's degree in relevant field, Less than 4 years of experience in Quality/Design Assurance
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