Shire Senior Device Development Engineer in Lexington, Massachusetts
The Senior Engineer will lead technical efforts for combination products and drug delivery device projects with limited oversight. As a hands-on technical lead/contributor and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners.
Responsibilities (% of time):
Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device and combination device regulations. – 50%
Establish and maintain detailed project plans, define risks and recommend contingency plans as required. 20%
Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. – 20%
Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. 5%
Lead or assist in deviation, complaint and failure investigations. 5%
Minimum of 7 years’ experience in the field of medical device or combination product development and commercialization is required.
Prior technical leadership experience with creating design control/technical file deliverables and manufacturing scale-up a plus.
A Bachelor’s of Science Degree in Engineering required, a Master’s of Science Degree preferred.
Experience in developing and commercializing regulated devices / 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 new 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.
Working knowledge of solid works desirable.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.