Position: Mechanical Engineer
We are presently seeking a Mechanical Engineer with a minimum of 3-5 years of experience in product design, and development. Direct experience with complex, electro-mechanical products in the medical device arena is a plus. BSME degree or higher is required.
Nature of Role: Reporting to the Director of Engineering, this highly creative individual executes, and occasionally leads mechanical design, and development activities through all phases of the medical product development process – from the initial design effort, through testing, and validation, and on to final manufacturing transfer.
- Execute the design and development of complex electro-mechanical medical devices and equipment
- Develop detail CAD design packages (3D data and 2D drawings)
- Use strong conceptual skills and abilities to build functional prototypes
- Maintain day-to-day communication with program managers and all appropriate program team members
- Research and procure sample components and develop high-functioning design prototypes
- Develop and execute prototype testing plans and protocols
- Stay current with cutting-edge medical device industry and technology trends to ensure innovative product design that will exceed client expectations and succeed in the marketplace
Requirements: Bachelor’s degree in Mechanical Engineering with 3-5 years of experience. A high degree of competence, and experience in the design of complex medical capital equipment, and disposable devices is required. Familiarity with appropriate FDA, QSR and ISO regulations: design controls, regulatory approval methods, and overall medical device industry knowledge is preferred. She possesses a high level of experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, etc. This role calls for expert level skill in the generation of detailed 3D and 2D CAD data (SolidWorks and/or ProEngineer), with additional experience with GD&T and general dimensioning best practices. Should have familiarity with FMEA, DFMA techniques, BOM structuring, test protocol writing, verification testing, quality inspection methodology, and report writing.
Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:
- Successful communication skills,business acumen, assertive decision-making ability, and the ability to clearly express ideas through sketches and drawings
- Strong conceptual skills and the ability to build functional prototypes
- Flexibility to multi-task and perform a wide range of activities
- Excellent computer skills, including MS Office proficiency
- Desire to implement new technologies and materials into world-class designs on tight schedules and within budget