Mechanical Engineer (Medical Devices) (Wayne)

Job Summary :

We are seeking a highly experienced and innovative Senior Mechanical Engineer to drive the development of advanced electro-pneumatic and mechanical systems. The ideal candidate will apply deep mechanical engineering expertise, lead complex design and re-design projects, and provide technical guidance to cross-functional teams and junior engineers.

Key Responsibilities :

Apply subject matter expertise in mechanical design, analysis, and system development.

Conceive and implement solutions to complex pneumatic, mechanical, and electrical design challenges.

Establish design objectives and contribute to writing specifications and comprehensive engineering reports.

Review and develop detailed product specifications.

Conduct conceptual and detailed design studies using MCAD, SolidWorks, and other engineering tools.

Collaborate with multidisciplinary teams throughout the design and development process.

Develop prototype hardware in coordination with internal manufacturing and external vendors.

Conduct rigorous testing to verify compliance with performance, safety, regulatory, and environmental requirements.

Apply Design for Manufacturability and Assembly (DFM&A) principles to product designs.

Generate and maintain detailed engineering documentation supporting the product development lifecycle.

Serve as a technical mentor and project lead, providing guidance to junior engineers and managing small to medium-sized projects.

Technical Expertise / Skills :

Advanced proficiency in SolidWorks CAD, MCAD / CAE tools, Microsoft Office Suite, Microsoft Visio, Microsoft Project, and Adobe Acrobat.

Strong background in materials and manufacturing methods, including :

Injection molding

Plastic extrusion

Metal casting, stamping, and machining

Additive manufacturing

Familiarity with ANSI / ISO dimensioning and drafting standards, including GD&T.

Experience with mechanical testing, measurement equipment, and statistical analysis of test data.

Understanding of regulatory requirements and document control systems, especially within medical device environments.

Knowledge of FDA, IEC, and UL standards for medical electronic equipment.

Capable of thermal, structural, and vibration analysis.

Skilled in mechanism design, analytical reasoning, and creative problem-solving.

Ability to operate lab and shop equipment (e.g., drill press, lathe, milling machine, oscilloscopes, DVMs, environmental chambers).

Experience with database and document management systems.

Minimum Qualifications :

BSME or MSME required.

Minimum of 10 years of progressive experience in mechanical design and product development.

Proven experience leading technical sub-projects and mentoring engineers.

Strong interpersonal, verbal, and written communication skills.