Senior Mechanical Engineer - Medical Devices

Suntra MedTech Solutions; Bedford (NH); Sur place; USD 95 000 - 130 000; Plein temps

Résumé du poste

Suntra MedTech Solutions in Bedford, NH, is seeking an experienced Mechanical Engineer to lead the design and development of medical device components, mechanisms, and assemblies. You will own product development from concept through commercialization, including requirements, design, prototyping, verification, and manufacturing transfer.

You will design robust, manufacturable solutions with appropriate materials, processes, tolerances, and cost considerations, while conducting risk management

Qualifications

• B.S. or M.S. in Mechanical Engineering or related field.
• 7–10 years of product development experience, including medical devices or regulated industries.
• Proven track record bringing products from concept to market.
• Proficiency in 3D CAD (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.

Responsabilités

• 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.

Connaissances

3D CAD

GD&T

DFM/DFA

Mechanical analysis

Verification testing

Reliability engineering

Human factors

Problem solving

Communication

Technical leadership

Independence & cross-functional lead

Formation

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

Experience in regulated medical device environments

Outils

SolidWorks

PDM systems

Description du poste

• 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.

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.

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 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.