Senior Manager, Mechanical Engineering (NPD) - Medical Device
High-level position to lead design development for this OEM medical device org.
This client is a top-rated medical device manufacturer based North of Boston
About Our Client
Our latest client is an international Class III OEM medical device manufacturer based on the North Shore of Boston Area. This company designs and manufactures complex electromechanical devices typically found in hospital and other healthcare settings.
- Provide appropriate strategic input to senior management.
- Responsible for overseeing mechanical engineering development for all NPD products
- Hire, train, and onboard new Mechanical Engineers to team
- Drive NPD projects to be completed effectively and efficiently on a timely basis.
- Provide engineering assistance in the design of new products including, but not limited to, probability of technical success, reliability, manufacturability (DFM/DFA) and cost.
- Act as liaison between assigned product engineering staff and Quality, Regulatory, Marketing, Manufacturing and any other relevant internal staff and outside resources.
- Ensure required technical documentation and files are robust and meet current standards.
- Lead Design Control procedures to ensure they meet current regulatory requirements and provide a clear and efficient product design process.
The Successful Applicant
- Bachelor of Science Degree in Engineering required, Masters dregree is preferred
- A minimum of 10 years of experience in mechanical R&D in the medical device space with a demonstrated track record of delivering products to market
- Expert knowledge of SolidWorks including flow and thermal analysis
- Subject matter expert in plastics and injection molding
- Previously demonstrated leadership experience in a management level mechanical engineering role with direct responsibility for managing an internal team and external design firms
- Strong knowledge of FDA QSR, CE Requirements, and V&V Testing for medical products
What's on Offer
- High-level Sr Manager position- managing all of Mechanical R&D and lead strategies
- New position in new division - expected to build out its own space and immediately hire Sr Engineers
- Dynamic, fast-paced, startup environment
- Strong base salary
- Bonus opportunity
- Competitive benefits package
- Top-rated medical device company