Mechanical Engineer (Contractor)

Location: Olathe, KS

• Contractor shall provide Vantage with Mechanical Engineering Consulting Services.

• Designing and developing mechanical components and systems for medical devices in alignment with applicable regulatory standards (ISO 13485, FDA, MDR)
• Creating and maintaining engineering documentation, including CAD models, drawings, tolerance analyses, and material specifications
• Collaborating with cross-functional stakeholders to support design, integration, and system-level problem solving
• Supporting design transfer activities, including supplier coordination, Design for Manufacturability (DFM), and Design for Assembly (DFA)
• Delivering engineering analyses and technical outputs with a high degree of autonomy and professional judgment

• Bachelor’s degree in mechanical engineering or a related field
• 5+ years of industry experience in the design, development, and testing of mechanical systems
• Intermediate to advanced proficiency in CAD modeling (SolidWorks preferred), including advanced part, surfacing, and parametric feature modeling
• Demonstrated ability to create detailed engineering drawing packages with proper dimensioning and tolerancing for moderately to highly complex assemblies
• Strong understanding of GD&T and tolerance stack-up analysis
• Experience applying Design for Manufacturability (DFM), Design for Assembly (DFA), and cost optimization principles, along with knowledge of manufacturing methods and production processes
• Experience performing static structural finite element analysis (FEA/FEM)
• Familiarity with CFD for simple fluidic systems, as well as heat transfer and fluid flow analysis (preferred)
• Experience leading or contributing to mechanical hazard analyses and product/hardware FMEA activities
• Ability to develop design input requirements for complex mechanical systems and components
• Working knowledge of medical and mechanical safety standards and the ability to design for compliance
• Experience with rapid prototyping, including 3D printing and model fabrication for usability testing
• Experience working within a regulated quality system (e.g., ISO 13485) is preferred
• Familiarity with biocompatibility considerations and ISO 10993-1 compliance (preferred)
• Understanding of sterilization methods and ability to evaluate material compatibility and effects (preferred)

• Ability to interact effectively with clients.
• Excellent critical thinking and analytical skills.
• High level of initiative with ability to self-manage.
• Strong written and verbal communication skills as well as reporting and presentational skills.
• Investigate clinical requirements.
• Regulatory agency experience including UL, CE and FDA approval processes preferred.