Mechanical Engineer

Point of Contact:
Engineering Manager/Director

Location:
Lyndhurst, NJ (Onsite Only)

Contract for 12 months and Fulltime perm both the option available (Both weekly 40 hours work)

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.

• 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.

• Bachelor’s Degree in Mechanical Engineering. Master’s Degree in Mechanical Engineering (preferred)
• 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.o Proficiency with advanced part modelling, surface modelling and parametric feature modelling is preferred.
• Utilize and maintain Solid Works 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-up.
• Ability to lead mechanical hazard analysis, product, and hardware FMEA process.
• 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.

• 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.