Senior Mechanical Engineer | Complex Single Use Medical Device
Boston, MA US
The Senior Mechanical Engineer will help manage the development of high quality surgical single-use disposable products. This role will have a hands on focus on the development of next generation instrumentation and sterile accessories to be paired with the company’s platform in a fast-paced entrepreneurial environment. The ideal candidate will be creative, highly motivated and have brought complex medical disposables from concept to commercialization. S/he will provide technical leadership through all stages of design control, including development, risk management, and verification/validation through transfer to manufacturing for this high growth company with positive recent news.
- Work with senior leadership team and cross-functional leads to define and technically evaluate new product ideas during feasibility phase
- Present results to Senior Management with proposed business direction
- Provide project direction and technical leadership from product concept through release to manufacturing.
- Lead the team through new product development activities, delivering the outputs of the design control procedure (including requirements creation, risk analyses, design trade-off discussions, phase reviews)
- Lead all design development technical activities including rapid prototyping to ensure all established project technical specifications are met and products are of high quality and readily manufacturable
- Perform injection mold validations and first article inspection protocols and reports
- 6+ years engineering experience in medical device development AND a minimum of 2 years designing complex Class 2 -3 disposable medical device products
- Expert in Solidworks 3D modeling, standard analysis tools and methodologies for fluid flow and thermal, mechanical detailing, geometric tolerance analysis, and documentation of the same.
- Strong knowledge of plastics and injection molding, rapid prototyping, materials and biocompatibility in humans.
- Medical device product development experience, working within the regulations of the FDA
- Strong understanding of medical device development processes including hands on experience with FDA CFR 820 and ISO 13485 regulation
Compensation : $90k - $110k(commensurate with experience), with Bonus
Direct Reports: Individual Contributor
Years of experience: 6+ years
Degree: Bachelor’s degree – Any Engineering
This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Legacy MedSearch was named to the 2019 Forbes list of Best Recruiting Firms in America.
single-use, medical, devices, biomedical, mechanical,
With a background in B2B Sales with Sprint’s enterprise division, Sean hit the ground running recruiting at Legacy. He quickly became an indispensable member of the Legacy team with his upbeat attitude, spirit for competition, and knack for finding all-star candidates for even the hardest to fill searches. He believes his best conversations are with perfect strangers, and welcomes to opportunity to connect with anyone and everyone.