Job Title: Sr. Mechanical Engineer - Medical Device
Location: Wayne, NJ Onsite
Duration: 12 Months Contract
Employment Type: W2 Contract
Rate: Up to $55 - $59/hr W2 (DOE)
Experience: 8+ Years
Position Overview:
We are seeking an experienced Sr. Mechanical Engineer to support mechanical engineering, product design, development, prototyping, testing, and design verification activities within a regulated medical device environment.
The ideal candidate will have strong hands-on experience with mechanical design, Design for Manufacturability and Assembly (DFM/DFA), SolidWorks/MCAD, mechanical components and assemblies, GD&T, prototype development, testing, and engineering documentation. Experience working with medical devices or medical equipment and familiarity with FDA, IEC, and UL requirements is highly preferred.
Key Responsibilities:
- Solve complex mechanical, pneumatic, electrical, and design problems.
- Design and develop mechanical components and assemblies.
- Create conceptual and detailed designs using SolidWorks/MCAD tools.
- Develop prototypes using internal manufacturing teams and outside vendors.
- Test products to ensure they meet design, safety, environmental, and regulatory requirements.
- Prepare engineering drawings, specifications, reports, and other design documents.
- Work closely with R&D, Manufacturing, Quality, Regulatory, and other engineering teams.
- Apply DFM/DFA principles while considering cost, tooling, and manufacturing processes.
- Troubleshoot mechanical design issues and develop practical engineering solutions.
- Perform mechanical measurements, testing, and analysis.
- Support and lead small-to-medium engineering projects.
- Provide technical guidance to junior engineers.
Required / Preferred Qualifications:
- Bachelor's degree in Mechanical Engineering or related field preferred.
- 8+ years of Mechanical Engineering experience.
- Medical Device or Medical Equipment experience strongly preferred/required.
- Strong hands-on experience in mechanical design and product development.
- Strong experience with SolidWorks or other MCAD tools.
- Experience with DFM/DFA.
- Knowledge of manufacturing processes including: Injection molding, Plastic extrusion, Casting, Sheet metal, Metal stamping, Machining, Additive manufacturing
- Experience designing complex mechanical assemblies with many components.
- Strong knowledge of GD&T, ANSI, ISO, and metric drafting standards.
- Experience with mechanical testing and measurement equipment.
- Knowledge of thermal, structural, and vibration analysis.
- Experience with document control systems in a regulated product development environment.
- Strong analytical, mathematical, mechanism-design, troubleshooting, and problem-solving skills.
- Familiarity with FDA, IEC, and UL standards for medical/electronic equipment.
- Ability to work with equipment such as pressure/flow meters, temperature & humidity chambers, data recorders, DVMs, and oscilloscopes.