Suntra MedTech Solutions · 2 weeks ago
Verification and Validation Test Lead - Med Device
Bedford, NH
Full-time
Hybrid
Senior Level
6+ years expSuntra MedTech Solutions is looking for a versatile individual with deep skills and experience in medical device development to participate in product development, supervise product verification and perform compliance activities. The role involves planning and directing verification testing of various components, overseeing test execution, and managing quality engineering processes.
Health CareLife ScienceManufacturingMedical Device
Responsibilities
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 estimates
Participate in internal and external audits
Qualification
Required
Bachelor's degree in Engineering, Computer Science, or similar technical discipline
6+ years' experience in Quality assurance including medical device design controls
Knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1
Solid understanding of IEC 62304 Medical Software Development Process
Familiarity with Risk Management standards ISO 14971
Excellent analytical and decision-making skills, as well as strong written and verbal communication
Ability to speak effectively before groups of clients or employees
Must be able to work onsite at least 3 days a week
Preferred
Experience using a variety of software development methodologies (Waterfall, Phase Gate, Agile, SCRUM, Kanban, etc.) is a plus
Experience in modern test automation is a plus
Benefits
100% company paid Dental, Life and Disability insurance
Three weeks of Vacation time
Additional Sick pay
10 paid holidays
Monthly lunches and socials
Bagel Tuesday
Company
Suntra MedTech Solutions
At Suntra MedTech Solutions™, we collaborate with visionary medtech leaders to turn pioneering thinking into tangible impact.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Drew Sunstein
Founder / Chairman of the Board
Recent News
2023-12-23
2023-12-23
Medical Design & Outsourcing
2023-12-23
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