Design Assurance Engineer, Medical Devices & Class II
Overview
Own design controls, risk management, verification and validation for Class II electro-mechanical medical devices at scale. Collaborate with product, quality, and regulatory teams to ensure compliant design history files and technical documentation. Work across development and sustaining activities in a global organization. This role emphasizes hands-on testing and documentation strategy that differentiates our design assurance process.
What You'll Do5
- 1Build and maintain design controls documentation and risk management plans for Class II devices
- 2Design and execute verification and validation activities to demonstrate device safety and performance
- 3Lead regulatory compliance activities and prepare technical documentation and risk assessments
- 4Collaborate with crossFunctional teams to maintain design history files and change control records
- 5Drive continuous improvement in quality systems and test strategies within the product lifecycle
Requirements5
- 13-5 years of experience with Class II electroMechanical medical devices
- 2Strong knowledge of design controls, risk management, verification and validation
- 3Experience with regulatory standards and medical device documentation
- 4Proficiency in creating and maintaining technical documentation and DHF
- 5Ability to work onsite in Marlborough, MA and collaborate with global teams
Salary Insight
$74 - $99k per year
Location
Required Skills
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