Senior Mechanical Engineer
$116,000–$116,000 year
On-siteLyndhurst, New Jersey, United States
Job Summary
Design, develop, and implement robust mechanical parts and assemblies for state-of-the-art medical devices, progressing from proof-of-concept prototypes to final production quality. Apply critical thinking to determine mechanical specifications, lead hazard analysis and FMEA processes, and generate engineering drawings with GD&T compliance. Manage concurrent projects by collaborating with electrical and firmware engineers to solve cross-functional challenges, while providing senior technical leadership and mentoring to a team of four to six engineers. Create documentation for manufacturing transfer and regulatory submission, support sustaining engineering activities including root cause investigations, and drive continuous improvement initiatives. Interface with business development to transfer new activities and prepare technical reports.
Required Qualifications
- 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)
- 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 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
- Regulatory agency experience including UL, CE and FDA approval processes
- Must be available for weekend shifts
- Must be able to lift 50 lbs
- Valid driver's license
- Must reside in or near the NJ or KS area
- Must be authorized for full-time employment in the United States
Desired Qualifications
- Master's Degree in Mechanical Engineering (preferable)
- Utilize and maintain SolidWorks PDM for version control, design release, and documentation traceability (experience preferred)
- Proficiency with advanced part modelling, surface modelling and parametric feature modelling is preferred
- 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
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