Mechanical Design Engineer (Medical Devices)

Position Summary

The Mechanical Design Engineer is responsible for the design, development, and lifecycle support of medical devices in compliance with ISO 13485 and applicable regulatory standards (e.g., FDA, MDR). This role involves translating user and clinical needs into robust, manufacturable mechanical designs while ensuring safety, reliability, and regulatory compliance.

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Key Responsibilities

•  Design and develop mechanical components and assemblies for medical devices from concept through production

•  Generate detailed CAD models, drawings, and specifications using SolidWorks

•  Conduct engineering analyses (FEA, tolerance stack-ups, thermal/mechanical simulations)

•  Develop and execute verification and validation (V&V) plans, including design verification testing (DVT)

•  Support risk management activities in accordance with ISO 14971

•  Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure design controls are met

•  Create and maintain Design History File (DHF) documentation per ISO 13485

•  Participate in design reviews, FMEA, and root cause investigations

•  Ensure designs are manufacturable (DFM/DFA) and cost-effective

•  Support supplier selection, component qualification, and production transfer

•  Investigate and resolve product issues, including CAPA support

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Required Qualifications

•  Bachelor’s or Master’s degree in Mechanical Engineering or related field

•  3 years (or as needed) of experience in medical device design or regulated industry

•  Proficiency in CAD (e.g., SolidWorks)

•  Familiarity with materials (plastics, metals, elastomers) used in medical devices

•  Experience with prototyping methods (3D printing, machining, injection molding)

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Preferred Qualifications

•  Knowledge of FDA 21 CFR Part 820 design control requirements

•  Strong knowledge of design controls under ISO 13485

•  Experience with risk management per ISO 14971

•  Experience with Class II or Class III medical devices

•  Experience with sterilization methods (EtO, gamma, autoclave)

•  Understanding of human factors engineering and usability

•  Experience with electrical/mechanical integration (mechatronics)

•  Familiarity with international regulations (EU MDR)

•  Experience with test method development and fixture design

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Key Competencies

•  Strong problem-solving and analytical skills

•  Attention to detail and documentation discipline

•  Ability to work in cross-functional, regulated environments

•  Effective communication and technical writing skills

•  Project management and prioritization abilities

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Work Environment

•  Office and lab environment with hands-on prototyping and testing

•  Occasional collaboration with manufacturing sites and suppliers