Senior Mechanical Engineer - Medical Devices

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.