Device Development Leader
Location:
Lexington , Massachusetts
Posted:
October 07, 2016
Reference:
14807BR
Primary Role

The Device Development Team Leader will lead Shire's cross functional Combination Device Development efforts for the injection system drug delivery projects. As a hands-on technical leader 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

• Provide project and technical leadership on cross functional teams for devices through clinical development, product registration and commercialization. Lead the creation of design control elements to comply with medical device regulations. - 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 and design validation. - 20%

• Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. 25%

• Lead or assist in deviation, complaint and failure investigations. 5%

Education & Experience Requirements

• More than 10 years experience in the field of medical device or combination product development and commercialization is required.

• Prior experience in PFS and/or auto injector design/development in collaboration with external partners a plus.

• Prior technical leadership experience with automation equipment development and manufacturing scale-up a plus.

• Minimum of a Bachelor's of Science Degree in Engineering required, a Master's of Science Degree preferred.

• Minimum of 5 years cross functional leading teams and projects.

• 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.

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.

Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
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Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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