Senior Mechanical Engineer
About The Position
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! Vantage MedTech is seeking a Senior Mechanical Engineer to join our team. This position will be responsible for designing, fabricating, and testing mechanical components for state-of-the-art medical devices in an environment where safety, efficacy, and innovation are compulsory. The ideal candidate is a self-starter with experience developing electro-mechanical devices, and a passion for being part of a team developing medical technologies that improve people’s lives. This is not a remote opportunity. Preference will be given to candidates who reside in or near the NJ or KS area. We do not offer relocation assistance.
Requirements
- Bachelor’s Degree in Mechanical Engineering.
- 10+ years of industry experience in design, development and testing of mechanical systems.
- Ability to generate mechanical architecture and componentry concepts for complex mechanical systems
- Intermediate to advanced proficiency in CAD modelling SW.
- Ability to generate, dimension, and tolerance engineering drawing packages for assemblies of moderate to high complexity.
- Understands GD&T and tolerance stack-ups.
- Ability to lead mechanical hazard analysis, product, and hardware FMEA processes.
- Ability to generate design input requirements for complex mechanical systems and components.
- Ability to interpret and design for compliance with medical / mechanical safety standards (IEC 60601-1).
- Experience with 3D printing and / or model making for usability testing.
- Machine shop experience to support rapid prototyping, fixture design, and hands-on debugging of mechanical systems
- Experience with design for manufacturing, assembly, and cost; manufacturing methods and production processes.
- Experience with static structural finite element analysis (FEA or FEM).
- 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.
- All applicants must be authorized for full-time employment in the United States.
Nice To Haves
- Master’s Degree in Mechanical Engineering
- Proficiency with advanced part modelling, surface modelling and parametric feature modelling
- Utilize and maintain SolidWorks PDM for version control, design release, and documentation traceability
- Ability to conduct biocompatibility analyses and design for compliance with ISO 10993-1
- Ability to select appropriate sterilization processes and analyze material effects
- Experience with CFD for simple fluidic systems
- Experience with heat transfer and fluid flow analysis
- Experience working in a safety-related quality process
- Regulatory agency experience including UL, CE and FDA approval processes
Responsibilities
- Quickly understand novel technologies and engage with moving them forward towards a product.
- Apply critical thinking and analytical skills to determine mechanical specifications for the medical device
- Design, develop, and implement highly robust mechanical parts and assemblies, starting with building a proof-of-concept prototype followed by the design and implementation of a final production quality medical device.
- Participate in technical design and design review meetings to discuss challenges related to the medical device.
- Work closely with electrical and firmware engineers to solve cross-functional design challenges.
- Create and maintain documentation packages suitable for manufacturing transfer and regulatory submission.
- Support sustaining engineering activities for released and legacy products, including root cause investigation, design updates, documentation changes, and field issue resolution.
- Drive continuous improvement and cost optimization (VAVE) initiatives to enhance product performance, manufacturability, and cost efficiency
- Support design changes and engineering change orders (ECOs), ensuring proper documentation, traceability, and compliance with design control processes
- Interface with Business Development to transfer new activities into the company.
- Manage a limited number of concurrent projects primarily of a mechanical scope in a team consisting of 4 - 6 engineers from multiple disciplines.
- Prepare project reports and other programs or technical documentation.
- Provide senior technical leadership and mentoring to the Mechanical Team members.
Benefits
- Comprehensive benefits package, including health, vision, and dental insurance.
- Generous Paid Time Off.
- Company retirement plan with matching.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
