Design Quality Engineer
Karwell TechnologiesCambridge, MA
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Overview
Remote
On-site
Job Description
Job Description: Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ultrasound/imaging systems.
Requirement:- Strong understanding of: Design controls & product lifecycle.
- Systems engineering.
- DFMEA / risk analysis.
- Requirement management tools (DOORS, Jama, etc.).
- V&V execution and review.
- Regulatory & Standards Knowledge
Mandatory: ISO 13485 ISO 14971 Preferred: IEC 60601 (electrical safety) IEC 62304 (software lifecycle) IEC 62366 (usability) Ultrasound / Imaging Domain (Preferred) Strong systems thinking Ability to: Identify design gaps early Drive risk-based decisions
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FAQs About Design Quality Engineer Jobs at Karwell Technologies
What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in Cambridge, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
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