Senior Mechanical Engineer
On-site · Olathe, Kansas, United States
Job Summary
Senior Mechanical Engineer needed to design, fabricate, and test mechanical components for state-of-the-art medical devices. Lead mechanical design efforts from concept through production, collaborate with electrical/firmware teams, create manufacturing transfer documentation, support sustaining engineering and field issue resolution, and drive cost-optimization initiatives. Role requires 10+ years in mechanical design and testing, CAD proficiency (SolidWorks PDM), lead hazard analysis and FMEA, and ability to ensure compliance with medical device standards (IEC 60601-1, ISO 10993-1) with experience in design for manufacturing, documentation, and regulatory submissions. Mentoring of the Mechanical Team and cross-functional collaboration with Business Development are essential; the position emphasizes initiative, strong communication, and project leadership across multiple concurrent mechanical projects. Must have a Bachelor’s in Mechanical Engineering (Master’s preferred) and operate in a non-remote, on-site capacity in Olathe, KS.
Required Qualifications
- Bachelor’s Degree in Mechanical Engineering
- 10+ years of industry experience in design, development and testing of mechanical systems
- Proficiency with CAD modelling and SolidWorks (PDM preferred)
- Ability to generate mechanical architecture concepts for complex systems
- Experience with design for manufacturing, assembly, and cost; manufacturing methods and production processes
- Experience with static structural FEA/FEM; CFD and heat transfer experience preferred
- Knowledge of design control processes, GD&T, and tolerance analysis
- Ability to lead mechanical hazard analysis, product and hardware FMEA
- Ability to interpret and design for IEC 60601-1 medical safety standards; ISO 10993-1 biocompatibility preferred
- Experience with regulatory processes including UL, CE and FDA approval processes
- Strong communication and teamwork skills; ability to mentor junior engineers
- Experience with 3D printing/model making for usability testing
- Experience with ECOs and documentation for regulatory submissions
- High initiative and self-management capabilities
- Client interaction abilities
- Regulatory agency experience preferred
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