Oxenham Group
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 (SolidWorks 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 (SolidWorks 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