Senior Mechanical Engineer

Vantage MedTech; Lyndhurst (OH); On-site; USD 116,000 - 139,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Job summary

Vantage MedTech is seeking a Senior Mechanical Engineer to drive design and development of medical device systems in a fast-paced environment.

You will lead mechanical design, perform analyses, and collaborate with electrical/firmware teams to ensure manufacturability and regulatory compliance. The role emphasizes mentoring a small team and delivering production-ready solutions.

Qualifications

• Bachelor’s degree in Mechanical Engineering; master preferred.
• 10+ years in design, development, and testing of mechanical systems.
• Ability to generate mechanical architecture and component concepts for complex systems.
• Proficient in CAD modelling SW with advanced part/surface modelling.
• SolidWorks PDM experience preferred.
• GD&T and tolerance stack-ups understanding.
• Design for manufacturing, assembly, and cost.
• Experience with FEM/FEA and CFD for thermal/fluid analyses.
• Experience in safety-related quality processes preferred.

Responsibilities

• Understand novel technologies and move them toward a product.
• Define mechanical specifications for the medical device.
• Design, develop, and implement robust mechanical parts and assemblies, from prototype to production.
• Participate in design reviews and cross-functional meetings.
• Collaborate with electrical and firmware engineers to resolve cross-functional challenges.
• Create and maintain documentation for manufacturing transfer and regulatory submission.
• Support sustaining engineering, including root cause investigations and ECOs.
• Drive continuous improvement and cost optimization initiatives.
• Interface with Business Development to transfer new activities into the company.
• Manage 4–6 engineers on mechanical scope within a multidisciplinary team.
• Prepare project reports and other technical documentation.
• Provide senior technical leadership and mentoring to the Mechanical Team.

Education

Bachelor’s Degree in Mechanical Engineering

Master’s Degree in Mechanical Engineering

Tools

SolidWorks

SolidWorks PDM

Job description

Job Title: Mechanical Engineer (Senior)

Location: Olathe, KS or Lyndhurst, NJ

Department: Hardware, Technical Services

Reports to: Engineering Manager, Mechanical / Director, Hardware

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.

**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.** __ **

Key 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.

Education and Experience:

• Bachelor’s Degree in Mechanical Engineering. Master’s Degree in Mechanical Engineering (preferable)

• 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.

  • Proficiency with advanced part modelling, surface modelling and parametric feature modelling is preferred.

• Utilize and maintain SolidWorks PDM for version control, design release, and documentation traceability (experience preferred).

• 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).

• Ability to conduct biocompatibility analyses and design for compliance with ISO 10993-1 preferred.

• Ability to select appropriate sterilization processes and analyze material effects preferred.

• 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).

  • Experience with CFD for simple fluidic systems is preferred.
  • Experience with heat transfer and fluid flow analysis is preferred.

• Experience working in a safety-related quality process is 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.

Top Benefits/Perks:

• Comprehensive benefits package, including health, vision, and dental insurance.

• Generous Paid Time Off.

• Company retirement plan with matching.

Salary Range: $116,000.00 To $139,000.00 Annually

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 for full-time employment in the United States. For more information, visit www.vantagemedtech.com