Description:

At Suntra we take products from concept to market, with a portfolio spanning life-sustaining pumps, surgical robots, and guidance systems, in-vitro and in-vivo diagnostic devices, 3D imaging systems, insulin and infusion pumps, wearable monitors with connectivity to mobile apps and cloud databases/web interfaces, and much more.

We are seeking a versatile individual with deep skills and experience in medical device development to participate in product development, supervise product verification and perform compliance activities.

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.  

We’re Looking For:

• 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 a minimum of 3 days per 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.

• Familiarity with embedded, mobile, cloud, and client-server architecture and database development
• Direct engineering experience developing hardware or software
• Customer-focused attitude

Why work with us:

• A comprehensive benefits package including Health Insurance with 100% company-paid Dental, Life and Disability insurance
• Three weeks’ vacation, unlimited sick time, plus 10 paid holidays 
• Monthly lunches and socials, “Bagel Tuesday” 

At Suntra MedTech Solutions, we’re driven by a simple but powerful idea: to make a measurable difference in patients’ lives by partnering with medtech companies to bring life-changing technologies to market. Formerly known as Sunrise Labs, we’ve spent over 30 years building a reputation for excellence. Now, as Suntra, we’re expanding that legacy with a broader, more integrated approach.

Our teams work at the intersection of consulting, engineering, and innovation, helping clients solve complex challenges from the earliest spark of an idea through to commercial readiness. Whether we’re uncovering strategic gaps, scaling an established pipeline, or designing with patients and providers in mind, we do it with rigor, heart, and purpose.

If you want to work where your expertise is valued, your curiosity is encouraged, and your work has real-world impact, Suntra is the place to grow. We’re building the future of medtech—come help us lead it.

We’re in southern New Hampshire where the mountains, lakes, and oceans are our playground, and Boston is just down the road. We offer great benefits and competitive salaries based on experience.

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.