Shire Lead Device Development Engineer in Lexington, Massachusetts
The Administration Kit and Administration System Qualification Lead will lead Shire’s cross functional Combination Device Development efforts and be a hands-on technical leader and device subject matter expert (SME). This person will provide project and engineering leadership in the device identification, feasibility, development, qualification and launch phases of administration kit development and or delivery system qualification activities. Area of focus may 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.
Provide project and technical leadership on cross functional teams for devices through clinical development, product registration and commercialization. Support the optimization 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, design validation, and delivery system qualification activities. – 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.
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 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.
KEY SKILLLS & COMPETENCIES
A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO14971.
Extensive knowledge of engineering principles, concepts and applications.
An aptitude for project foresight and contingency planning.
Effective planning and organizational skills.
Excellent writing and oral communication skills.
Strong knowledge of project management techniques, tools and metrics.
Ability to mentor technical and cross functional team members.
Strong collaboration skills with external partners.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.
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.