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Shire Sr. Device Development Engineer - Systems in Lexington, Massachusetts
The Lead will lead Shire’s cross functional Combination Device Development efforts and Qualification of Medical Devices used in clinical studies and for commercial release. The ideal candidate will be a hands-on project and 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 of combination products. Area of focus will also include identification of user needs, specification development, test development, design verification and validation testing, risk assessments 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 foster strong collaborative relationships with external design/development, manufacturing partners and service providers. Provide critique and design guidance on hardware and firmware designs to ensure proper implementation and traceability of design outputs as compared to design inputs – 25%
Establish and maintain detailed project plans, define risks and recommend contingency plans as required. Provide support of Risk Management activities, working with Design Quality partners –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%
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 5 years experience in the field of medical device or combination product development and commercialization is required.
Proven track record of developing wearable injectors and/or infusion pumps preferred.
A Bachelor’s of Science Degree in Electrical Engineering required, Masters of Science preferred.
Minimum of 2 years leading cross functional 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, IEC, 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 required.
DFSS certification is highly desirable.
Prior experience leading projects with external design, development and manufacturing partners.
Prior experience managing and mentoring direct reports desirable.
Key Skills & 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.
Working knowledge of IEC60601-1 and collateral standards and other related standards.
Familiarity with the software development process compliant to ISO62304.
Experience with Requirements Management software programs such as Doors.
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.
Notice to Employment / Recruitment Agents:
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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.
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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.