Verification & Validation Test Lead at Sunrise Labs Inc

Bedford, New Hampshire, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Apr, 26

Salary

0.0

Posted On

13 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Medical Device Development, Test Protocols, Verification Testing, ISO 13485, IEC 60601-1, IEC 62304, Risk Management, Analytical Skills, Decision-Making Skills, Communication Skills, Software Development Methodologies, Test Automation

Industry

Engineering Services

Description

Description At Sunrise we’re working on groundbreaking, life changing medical devices. Our engineering excellence is guided by our values centered on client success, uncompromising integrity, constant respect for people, collaboration, innovation and continuous learning. Sunrise 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. Why work with us? A comprehensive benefits package including 100% company paid Dental, Life and Disability insurance. Three weeks of Vacation time, additional Sick pay plus 10 paid holidays Monthly lunches and socials, “Bagel Tuesday” 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. Requirements 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. 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.

Responsibilities

The Verification & Validation Test Lead will plan and direct verification testing of various components and systems, design test protocols, and oversee test execution. They will also manage quality engineering processes and participate in internal and external audits.