Mechanical Engineer (Contractor)

• 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.

Vantage MedTech is committed to providing equal opportunity in the selection of contractors and service providers. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other characteristic protected by applicable law. Contractor selection decisions are based on qualifications, expertise, experience, and business needs. All contractors must be authorized to perform services in the United States without sponsorship. For more information, visit