Shire Device Technical Lead in Lexington, Massachusetts
The Device Development Technical Team Leader will lead Shires cross functional Combination Device Development efforts for drug delivery device 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.
The technical leader is expected to be knowledgeable about the overall device development program (i.e., Design Control, Change Control, Device Regulations, etc.) in order to be strategic in planning, program progress oversight/execution, communication, and process management.
Responsibilities (% of time):
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.
Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
Lead all project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation.
Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.
Lead or assist in deviation, complaint and failure investigations.
Participate in the operational planning activities of the DT including Strategic Device Plans, Target Device Profile (TDP), TPP alignment, Long Range Plan, Life Cycle Management Plan, and Geographical Expansion Plan, ensuring alignment to program strategy.
Collaborate with DCL, GDL, PSL and DT members to ensure coordinated evaluation of product opportunities/ scenarios and development of comprehensive, integrated recommendations (e.g., to Governance Committees) and strategic and operational product plans based on program defined objectives and priorities.
Promote visibility and transparency of information within the DT, across DT sub-teams and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge, identify and communicate product and DT related objectives, issues, risks, and where applicable, facilitate cross-DT discussion on impact.
Expertise in design controls, biocompatibility, sterilization validation, packaging validation, and shelf life stability programs
Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.
Establishing and fostering strong collaborative relationships with external design/development, manufacturing partners and service providers.
Works closely with the procurement team on contract vendor selection, outsourcing models, and vendor evaluation audits, for medical device partners and combination products.
Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects.
To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.
Represents device development and external manufacturing on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions.
Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.
A Bachelor’s of Science Degree in Engineering required, a Master’s of Science Degree preferred.
More than 10 years experience in the field of medical device or combination product development and commercialization is required.
Prior experience in 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 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.
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.