Mechanical Engineer

Our customer is a lobal medical device company. The company is hiring 6 Mechanical Engineers to support verification and validation projects and end of life projects. The ideal candidate has 2+ years of experience of R&D work as a mechancial engineer in a regulated industry, strong documentation experience, and electro-mechanical device experience.
Responsibilities

• Interpret customer specifications to define mechanical design requirements
• Create 3D models and detailed fabrication/assembly drawings using CAD (Solid Works preferred)
• Perform first-principles analysis and tolerance analysis
• Develop, prototype, and evaluate mechanical components and systems
• Troubleshoot and resolve design and process issues
• Collaborate with internal and external teams on part fabrication, inspection, and testing
• Develop and execute design verification protocols and write technical reports
• Design and develop test methods, fixtures, prototype tooling, and equipment
• Analyze data to provide recommendations and support design improvements
• Contribute to project planning and documentation using electronic systems
• Train technicians and operators on new processes
• Work independently with guidance on task prioritization

• Bachelor’s degree in Engineering (Mechanical preferred); 2–4 years of relevant experience or MS with less than 1 year
• Proficiency in 3D CAD design (Solid Works strongly preferred)
• Experience with medical device or electromechanical equipment design
• Knowledge of injection molding, extrusion, sheet metal, casting, and machining processes
• Familiarity with DFM/A, GD&T, metric ANSI/ISO drafting standards, and statistical data analysis
• Experience using test equipment (pressure/flow meters, temp/humidity chambers, DVMs, oscilloscopes, etc.)
• Understanding of medical device standards: ISO 13485, ISO 7198, and GMP
• Skilled in documentation and use of electronic document control systems
• Strong analytical, problem-solving, and communication skills
• Familiar with Agile Scrum and Waterfall project management methods
• Proficiency in Microsoft Office; experience with Visio and Project preferred