Senior Mechanical Engineer

Suntra MedTech; Bedford (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical technology firm in Bedford, NH, is seeking a Mechanical Engineer to lead the design and development of medical device components. The role involves taking products from conception to market, conducting risk management, and collaborating with cross-functional teams. Ideal candidates will have 7–10 years of experience in product development, particularly in regulated industries. Proficiency in CAD tools like SolidWorks and strong problem-solving skills are essential. This position offers opportunities for mentoring and technical leadership.

Qualifications

• 7–10 years of product development experience, including 5 years in medical devices.
• Demonstrated experience bringing products from concept to market.
• Familiarity with verification testing, reliability engineering, and human factors considerations.

Responsibilities

• Lead mechanical design and development of medical device components.
• Own product development from concept through commercialization.
• Conduct risk management activities, including design reviews.
• Create and maintain engineering documentation, including CAD models.
• Collaborate with cross-functional teams to deliver integrated products.

Skills

Problem-solving

Communication

Technical leadership

3D CAD proficiency

DFM/DFA knowledge

Mechanical analysis

Education

B.S. or M.S. in Mechanical Engineering

Tools

SolidWorks

Job description

Description

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.

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 systemdesign.
• 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 devices.
• Fluidics, micro-mechanisms, or disposable device design.
• Hands-on prototyping and test fixture development.
• Exposure to project management tools and agile development methodologies.