Mechanical Engineer (Contractor)
On-site · Olathe, Kansas, United States
Job Summary
Independent Mechanical Engineer contractor for a defined 12-month term to design and develop mechanical components and systems for medical devices, create and maintain CAD models and drawings, perform static structural FEA/FEM and CFD analyses, apply DFM/DFA, support design transfer and supplier coordination, and deliver engineering outputs with autonomy. Responsibilities include documentation, regulatory alignment with ISO 13485, FDA/MDR compliance, hazard analyses and FMEA, rapid prototyping (3D printing), and collaboration with cross-functional teams under ISO 13485 quality systems; requires SolidWorks proficiency, GD&T, and experience with medical device programs and manufacturing processes.
Required Qualifications
- Bachelor’s degree in mechanical engineering or a related field
- 5+ years of industry experience in design, development, and testing of mechanical systems
- Proficiency with CAD modeling (SolidWorks preferred) including advanced part modeling and surfacing
- Experience creating detailed drawing packages with GD&T and tolerancing for complex assemblies
- Knowledge of GD&T and tolerance stack-up analysis
- Experience applying DFM and DFA and knowledge of manufacturing methods and production processes
- Experience performing static structural finite element analysis (FEA/FEM)
- Familiarity with CFD for simple fluidic systems and heat transfer/flow analysis (preferred)
- Experience leading or contributing to mechanical hazard analyses and product/hardware FMEA
- Ability to develop design input requirements for complex mechanical systems
- Working knowledge of medical and mechanical safety standards and design for compliance
- Experience with rapid prototyping including 3D printing
- Experience with regulated quality systems (ISO 13485 preferred)
- Familiarity with biocompatibility considerations and ISO 10993-1 (preferred)
- Understanding of sterilization methods and material compatibility (preferred)
- Regulatory agency experience including UL, CE and FDA approval processes (preferred)
- Ability to interact effectively with clients
- Strong communication and self-management skills
- Authorized to perform services in the United States without sponsorship (no visa provided)
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