Quality Assurance Test Lead

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, unlimited Sick pay plus 10 paid holidays
• Monthly lunches and socials, “Bagel Tuesday”
• Hybrid work options

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.

• 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.
• 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.