Senior Mechanical Engineer - Medical Devices

Looking to bypass the grinding daily commute into Boston/Cambridge and still work on the most innovative new technologies in healthcare?
We develop new medical technologies, including work with MIT on ingestible sensing, and programs involving artificial-womb technology, surgical robotics, and implanted cardiac assist devices. Our Engineers work across a variety of ambitious development programs with a collaborative engineering culture and flexible hybrid working environment, one day per month (on average) in our state-of-the-art facility in Bedford, NH. We design products with our clients and then move on to designing the the next new and exciting product.

Responsibilities

- Lead mechanical design and development of medical device components, mechanisms, and assemblies.

- Own product development from concept through commercialization, including requirements, design, prototyping, verification, and manufacturing transfer.

- Design robust, manufacturable solutions using appropriate materials, processes, tolerances, and cost considerations.

- Conduct risk management activities, including design reviews and FMEA, to ensure compliance with applicable regulations and standards.

- Create and maintain engineering documentation, including CAD models, drawings, and Design History Files (DHFs).

- Collaborate with electrical, software, quality, manufacturing, and regulatory teams to deliver integrated products.

- Mentor and provide technical guidance to junior engineers.

- Stay current on medical device technologies, regulations, and industry best practices.
Requirements
Qualifications

- B.S. or M.S. in Mechanical Engineering or a related field.

- 7–10 years of product development experience, including at least 5 years in medical devices or other regulated industries.

- Demonstrated experience bringing products from concept to market.

- Proficiency in 3D CAD (e.g., SolidWorks) and PDM systems.

- Strong knowledge of DFM/DFA, GD&T, and mechanical system design.

- Experience with mechanisms and mechanical analysis.

- Familiarity with verification testing, reliability engineering, and human factors considerations.

- Excellent problem-solving, communication, and technical leadership skills.

- Ability to work independently and lead cross-functional design efforts.
Preferred Experience

- Class II or Class III medical device experience is preferred, but we will gladly look at standout mechanical talent from other safety-critical compliance sectors (e.g., Aerospace, Defense, Robotics).

- Fluidics, micro-mechanisms, or disposable device design.

- Hands-on prototyping and test fixture development.

- Exposure to project management tools and agile development methodologies.