Responsibilities:

• Lead the design, development, and integration of complex mechanical components, mechanisms and assemblies for medical devices.
• Own product development activities from concept through commercialization, including requirements definition, feasibility studies, design, prototyping, verification, and transfer to manufacturing.
• Apply knowledge of materials, manufacturing processes (e.g., injection molding, machining, extrusion), and tolerance analysis to ensure robust, cost-effective designs.
• Perform risk analysis, design reviews, and FMEA to ensure compliance with regulatory standards (ISO 13485, FDA 21 CFR Part 11, IEC 60601, etc.).
• Create and maintain detailed engineering documentation including CAD models, drawings, and design history files (DHFs).
• Collaborate with cross-functional teams (electrical systems, software, quality, manufacturing, regulatory) to deliver integrated solutions.
• Provide technical mentorship and guidance to junior engineers and interns.
• Stay current with industry trends, regulatory requirements, and emerging technologies relevant to medical devices.

We’re Looking For:

• Education: B.S. or M.S. in Mechanical Engineering or related discipline.
• Experience: 7–10 years of hands-on product development experience, with at least 5 years in the medical device or regulated industry.
• Proven track record of bringing products from concept to market.
• Strong proficiency in 3D CAD (e.g., SolidWorks) and PDM systems.
• Deep understanding of design for manufacturability (DFM), design for assembly (DFA), and GD&T.
• Experience of mechanisms (kinematics, dynamics, machine design)
• Familiarity with human factors engineering, usability, and biocompatibility considerations.
• Knowledge of verification testing methods and reliability engineering.
• Excellent problem-solving, analytical, and communication skills.
• Ability to work independently and lead cross-functional design efforts.

Preferred Skills:

• Experience with Class II or Class III medical devices.
• Experience with fluidics, micro-mechanics, or disposable device design.
• Hands-on prototyping and test fixture development.
• Exposure to project management tools and agile product development methodologies.

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, plus10 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.