Shire Senior Engineer, Advanced Drug Delivery Tech Development in Lexington, Massachusetts
Devices/delivery systems constitute the “user interface” for patients and customers using Shire products, and key to the user experience. The Shire Device Center of Excellence and Technology Development (DCoE&TD) in Lexington, Massachusetts allows Shire to explore how next generation therapeutics, emerging technologies, data analytics and new care models can improve patient health while reducing clinical, psychosocial and economic burden. Our team shares a passion for challenging conventional wisdom and creating an environment that appreciates the risk-reward aspects of developing breakthrough concepts. Working closely with commercial, clinical, device and drug product partners, the DCoE&TD group is responsible for driving early stage device/delivery system initiatives to “entry to development.”
Key activities include:
Contribute to the identification and assessment of new/emerging drug delivery technologies with potential application to Shire products
Contribute to the realization of novel drug delivery/device concepts that address key market and user needs by leveraging enabling technologies
Lead prototyping and feasibility testing and assessments (in collaboration with external partners).
Lead tech transfer of projects to product development group; contribute to drafting of key early Design Control documents such as Design and Development Plan (DDP), User Needs Document (UND), Product Requirements Document (PRD), Risk Assessments etc.
Collaborate with commercial and clinical partners in user research efforts to uncover unmet user needs
Collaborate with commercial stakeholders to drive business case and device strategy development for project justification and approval by governing bodies
Support development of Target Device Profile (TDP) for technology development projects
Monitor market and competitive intelligence for impact on device strategy
Identify development partners/supplier and nurture relationships through contracting.
Provide support to other DCOETD technology areas (eHealth and Diagnostics) as assigned (as needed).
Define early stage activities and monitor progress against key milestones
Ensure work and team activities are aligned with all relevant quality, regulatory, HSE, GLP, and GMP requirements.
Responsibilities (% of time):
30% (25-40%): Feasibility testing and assessment of product concepts and emerging drug delivery technologies
20% (15-30%): Drug delivery technology exploration
20% (15-30%): Project TDP, business case, and strategy development
15% (10-20%): Supplier partnership development
15% (10-20%): User Research support
Education and Experience Requirement
BS/BEng in relevant engineering or scientific area of study (typically, mechanical, plastics or biomedical engineering) with minimum five (5) years experience in Medical Device development.
MS in relevant engineering or scientific area of study (typically, mechanical, plastics or biomedical engineering) with minimum (3) years experience in Medical Device development.
Drug (small molecule and/or biologic) delivery experience;
Experience with combination products;
Demonstrated experience in performing concept prototyping, feasibility testing and assessments
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.