Quality underlies everything we do at Sunrise and we are seeking an experienced Test Manager to direct and oversee verification planning and execution on development projects.
Sunrise is looking for an individual with deep skills and experience in medical device development to participate in product development, supervise product verification and perform compliance activities. The candidate would have extensive experience verifying software, mechanical, and electronics in an ISO 13485 certified medical quality management system (QMS). Lifecycle Management, Software Quality Assurance (SWQA) and automated test experience is a plus.
At Sunrise you will:
We will look for:
- Plan and Direct verification testing of electrical, mechanical, and software components and systems as applicable
- Design test protocols; oversee test execution
- Direct quality engineering in identifying, recommending, implementing, managing, and administering process and software validation
- Provide feedback on and participate in reviews for requirements, architecture, and designs
- Support proposal creation and estimate
- Participate in internal and external audits
You'll stand out with:
- Bachelor’s degree in Engineering, Science, or similar technical discipline
- 6+ years experience in Quality Management including medical device design controls
- Extensive knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1
- Excellent analytical and decision making skills, as well as strong written and verbal communication
- Ability to speak effectively before groups of clients or employees
- Familiarity with Risk Management standards ISO 14971:2012
- Experience using a variety of software development methodologies (Waterfall, Phase Gate, Agile, SCRUM, Kanban, etc.) is a plus
- Solid understanding of IEC 62304 Medical Software Development Process is a plus
- Experience in modern test automation is a plus
We're in southern New Hampshire where the mountains, lakes, and ocean are our playground, and Boston is just down the road. We offer great benefits and competitive salaries based on experience. We encourage you to send your resume and cover letter to Human Resources at: email@example.com
We do not accept resumes from staffing agencies or search firms unless a valid search agreement is in place with the agency for a specific position.