We’ve been engaged to search for a Senior Mechanical Engineer with 7-10 years of experience in medical product design and development. This role will work in a dynamic team environment, partnering with clients on the development of medical devices. The Senior Engineer will lead mechanical design and development activities through all phases of the medical product development process beginning with initial design effort, through testing and validation, and on to final manufacturing transfer.
Execute the design and development of complex medical devices and equipment
Develop detail 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
Candidates should have 7-10 years of experience with a BSME degree.
Competence and experience in the design of complex medical capital equipment and disposable devices is required.
Familiarity with appropriate FDA, QSR and ISO regulations 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.
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