Sr. Mechanical Engineer - Medical Devices

Suntra MedTech Solutions; Bedford (NH); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Suntra MedTech Solutions is seeking a Senior Mechanical Engineer to drive the design and development of medical device components and assemblies. You will own projects from concept to commercialization, balancing manufacturability, cost, and regulatory considerations.

You will collaborate with cross-functional teams and mentor junior engineers in a flexible hybrid environment with one day per month in Bedford, NH. A strong background in regulated medical devices is required.

Qualifications

• B.S. or M.S. in Mechanical Engineering or related field.
• 7-10 years of product development experience; at least 5 years in medical devices or regulated industries.
• Proven history of bringing products from concept to market.
• Strong CAD proficiency and experience with design for manufacturability.

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 considering materials, processes, tolerances, and cost.
• Conduct risk management activities, including design reviews and FMEA, for regulatory compliance.
• Create and maintain engineering documentation, CAD models, drawings, and 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.

Skills

3D CAD

DFM/DFA

GD&T

Risk Management

FMEA

Leadership

Cross-functional Collaboration

Verification Testing

Reliability Engineering

Mentorship

Education

B.S./M.S. Mechanical Engineering

Tools

SolidWorks

PDM systems

Job description

Senior Mechanical Engineer - Medical Devices

Description

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).
• Hands-on prototyping and test fixture development.
• Exposure to project management tools and agile development methodologies.