Senior Mechanical Engineer

Senior Mechanical Engineer

Proven is hiring a Senior Mechanical Engineer on behalf of our client, an industry innovator in comprehensive design and manufacturing services for cutting-edge medical technologies. Supporting the advancement of healthcare solutions from initial concept to full product realization, our client develops and manufactures critical devices used in treating heart failure, cancer, stroke, gene therapy, and other complex medical conditions. This full-time role offers top-tier talent the opportunity to contribute to meaningful work that improves the lives of hundreds of thousands of patients worldwide within a collaborative, growth-oriented environment. The Senior Mechanical Engineer 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.

Location: Olathe, KS or Lyndhurst, NJ

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.