The Lead Device Development Engineer will lead Shire’s cross functional Combination Device Development efforts specific to Administration Kits and associated qualification. The ideal candidate will be a hands-on technical leader, considered a device subject matter expert (SME), and will provide project and engineering leadership in the device identification, feasibility, development, qualification and launch phases of administration kit development. Area of focus will also include identification of user needs, specification development, test development, design verification and validation testing, risk assessments, and project team oversight with extensive collaboration with internal and external partners and stakeholders.
Responsibilities (% of time):
- Provide project and technical leadership to cross functional teams for projects through clinical development, product registration and commercialization. 25%
- Establish and maintain detailed project plans, define risks and recommend contingency plans as required. 25%
- Lead all project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities. 20%
- Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. 25%
- Support the optimization of design control elements to comply with medical device regulations Lead or assist in deviation, complaint and failure investigations. 5%
- More than 10 years experience in the field of medical device or combination product development and commercialization is required.
- A Bachelor’ of Science Degree in Engineering required, a Master’ of Science Degree preferred.
- Minimum of 5 years cross functional leading teams and projects.
- Experience in developing and commercializing regulated combination products under Design Control (21 CFR 820) and ISO14791 requirements.
- Proven track record of developing and gain regulatory approval of drug delivery systems a plus
- Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..).
- Strong hands on technical leadership skills with a track record of delivering products to market.
- Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences, is desirable.
- DFSS certification is highly desirable.
- Prior experience leading projects with external design, development and manufacturing partners
Location/Region: Lexington, MA