Senior Medical Device Mechanical Engineer - Hybrid

Suntra MedTech Solutions; Bedford (NH); Hybrid; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

3D CAD

DFM/DFA

GD&T

Risk Management

FMEA

Leadership

Cross-functional Collaboration

Verification Testing

Reliability Engineering

Mentorship

Ausbildung

B.S./M.S. Mechanical Engineering

Tools

SolidWorks

PDM systems

Jobbeschreibung

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.