Sr. Mechanical Engineer

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Sr. Mechanical Engineer
Location: Wayne, NJ
Duration: Long Term

Job Overview

We are seeking an experienced Sr. Mechanical Engineer with 10+ years of experience in mechanical design and product development of electro-pneumatic assemblies. The candidate will support product design, prototyping, testing, and development of medical devices or medical equipment, ensuring designs meet performance, safety, regulatory, and manufacturing requirements.

Key Responsibilities

• Develop mechanical, pneumatic, and electrical design solutions for complex engineering problems.
• Conduct conceptual design studies using SolidWorks, MCAD, and other engineering tools.
• Develop and review product specifications, engineering reports, and design documentation.
• Design and develop prototypes using internal manufacturing resources and external vendors.
• Support product testing and verify designs against performance, environmental, safety, and regulatory requirements.
• Apply Design for Manufacturability and Assembly (DFM&A) principles to product designs.
• Collaborate with cross-functional engineering teams on product development activities.
• Support mechanical design, analysis, testing, and troubleshooting.
• Provide technical guidance and training to junior engineers.
• Lead small to medium engineering projects and coordinate project timelines and activities.
• Support design documentation and electronic document control activities.

Required Qualifications

• Bachelor's or Master's degree in Mechanical Engineering (BSME/MSME).
• Minimum 10 years of related experience in mechanical design and product development of electro-pneumatic assemblies.
• Experience providing technical supervision of engineering sub-projects.
• Advanced proficiency in SolidWorks and MCAD/CAE software preferred.
• Experience with Design for Manufacturability and Assembly (DFM&A).
• Knowledge of injection molding, plastic extrusion, casting, sheet metal, metal stamping, additive manufacturing, and machined metal components.
• Knowledge of GD&T, ANSI/ISO dimensioning and drafting standards, and mechanical measurement techniques.
• Experience with mechanical testing, statistical analysis, thermal and structural analysis, and vibration testing.
• Experience with electronic document control systems in medical device or medical equipment design and development.
• Knowledge of FDA, IEC, and UL standards related to medical electronic equipment.
• Ability to operate engineering test equipment, including pressure and flow measurement equipment, temperature/humidity chambers, data recorders, DVMs, and oscilloscopes.
• Familiarity with basic shop equipment, including drill presses, lathes, milling machines, brakes, and shears.
• Proficiency in Microsoft Office and Adobe Acrobat.
• Experience with Microsoft Visio, Microsoft Project, and database management software preferred.
• Strong analytical, problem-solving, communication, teamwork, and project management skills.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.