Senior Mechanical Engineer

Position: Senior Mechanical Engineer

We are presently seeking a Senior Mechanical Engineer with 7-10 years of experience in medical product design, and development. Direct experience with complex, electro-mechanical products is a plus. BSME degree or higher is required.

Nature of Role: Reporting to the Head of Engineering or a department manager, this individual will lead 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.

Responsibilities:

  • Execute the design and development of complex electro-mechanical medical devices, and equipment
  • Develop detailed CAD design packages (3D data and 2D drawings)
  • 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 7-10 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 critical to success in this role. Candidate must possess 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 (ProEngineer and/or SolidWorks), with additional experience with GD&T, and general dimensioning best practices. Must 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-starter with the following qualities are encouraged to apply:

  • Successful communication skills, business acumen and assertive decision-making ability
  • Flexibility to multi-task and perform a wide range of activities
  • Excellent computer skills, including MS Office proficiency

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