The Role
The Mechanical Engineer will design and develop medical devices while ensuring compliance with regulations. Responsibilities include CAD modeling, engineering documentation, collaborating with stakeholders, and supporting design transfer activities.
Summary Generated by Built In
Job Title: Mechanical Engineer (Independent Contractor)
Duration: 12-months (possibility of extension)
Employment Type: Independent Contractor (1099)
Department: Hardware, Technical Services
Point of Contact: Engineering Manager/Director
Location: Olathe, KS
Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We develop and manufacture new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide. If this is something you aspire to, we would like to talk with you!
* This is an independent contractor role for a defined term of approximately 12 months, with potential for extension. This role is not an employee position and is not eligible for company sponsored benefits.
Services:
Duration: 12-months (possibility of extension)
Employment Type: Independent Contractor (1099)
Department: Hardware, Technical Services
Point of Contact: Engineering Manager/Director
Location: Olathe, KS
Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We develop and manufacture new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide. If this is something you aspire to, we would like to talk with you!
* This is an independent contractor role for a defined term of approximately 12 months, with potential for extension. This role is not an employee position and is not eligible for company sponsored benefits.
Services:
- 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 values a diverse team and is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized to perform services in the United States without sponsorship. For more information, visit www.vantagemedtech.com
Skills Required
- Bachelor's degree in mechanical engineering or a related field
- 5+ years of industry experience in mechanical systems design, development, and testing
- Intermediate to advanced proficiency in CAD modeling (SolidWorks preferred)
- Demonstrated ability to create detailed engineering drawing packages with proper dimensioning and tolerancing
- Strong understanding of GD&T and tolerance stack-up analysis
- Experience applying Design for Manufacturability (DFM), Design for Assembly (DFA)
- Static structural finite element analysis (FEA/FEM) experience
- Familiarity with CFD for fluidic systems and heat transfer analysis
- Experience with 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
- Experience with rapid prototyping, including 3D printing
- Experience working within a regulated quality system (ISO 13485 preferred)
- Familiarity with biocompatibility considerations (ISO 10993-1 compliance preferred)
- Understanding of sterilization methods and material compatibility
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The Company
What We Do
Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. Partnering with the world’s most innovative MedTech start-ups and large medical device companies, we offer feasibility support, product development and prototyping, new product development, clinical and commercial manufacturing, and after-market services to support every phase of the product life cycle. Our clients can leverage our proprietary Advantage Platforms™, accelerating product development timelines. Our manufacturing approach is structured to serve the changing needs of our clients, supporting small-quantity clinical or First-in-Human builds and can scale to accommodate full launch quantities. Vantage MedTech has facilities in Moonachie, New Jersey and Lenexa, Kansas. Visit www.vantagemedtech.com for more information
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