Mechanical Engineer (Contractor)

Job Location:

Olathe, CO - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

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 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.

Scope:

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

Qualifications and Experience:

Bachelors 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)

Additional Qualifications:

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

Required Experience:

Senior IC

Contractor shall provide Vantage with Mechanical Engineering Consulting Services.

Scope:

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

Qualifications and Experience:

Bachelors 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)

Additional Qualifications:

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.