Design Assurance Engineering Manager - Medical Device
Seeking Medical Device Design Quality Engineers with management experience
Publicly-held, OEM complex medical device company based in the Waltham MA area.
About Our Client
Our latest client is a rapidly growing OEM medical device company based in the Waltham Area. This company is FDA-approved for several complex capital equipment devices and has recently transitioned into a publicly-traded company.
- Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Support global product registration needs by acting as liaison for technical questions as it pertains to design control and compliance to external standard.
- Ability to support any Product Line Portfolios and actively supports 1 or more Product Line Portfolios
- Lead cross-functional teams in the development, update, and release of risk management documentation inclusive of but not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA's (Use, Design & Process), Fault Tree Analysis (FTA)
- Manage, train and coach DQEs and Associate DQEs. Provide training and business process expertise within and outside the quality department. Provide support to other Global Quality projects as needed
- Lead or participate in translation of Voice-of-Customer into development Requirements
The Successful Applicant
- Bachelor's Degree (B.S.) Required in mechanical engineering, mechanical engineering technology, biomedical engineering (or other technical degree applicable to position being filled) or related discipline from an accredited university
- Mast have prior management experience
- Minimum of eight (8) years of Engineering experience supporting New Product development in the medical device industry.
- Experience in the application of design controls and risk management within the medical device industry
- Experience in product development with complex systems (mechanical, electrical, software, chemistry)
What's on Offer
- Strong base salary
- 10%+ bonus
- Management position - this role will manage 2+ engineers
- Reports up to senior leadership with room for growth
- Stock purchasing program
- Competitive benefits package
- Voted top-rated company to work for in New England
- Market leader within its medical device type