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Shire Senior Engineer, Connected Devices and Digital Health in Lexington, Massachusetts
The Shire Device Center of Excellence(DCoE) 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 embraces the risk-reward aspects of developing breakthrough concepts. Working closely with commercial, device and drug product partners, for digital health and connectivity the DCoE group is responsible for driving early stage initiatives to delivery and launch.
The Sr. Engineer will drive Shire’s cross functional Combination Device Development efforts for smart devices and digital health projects especially electromechanical perspective of the project. As a hands-on individual contributor and connected device subject matter expert (SME), the candidate will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of electromechanical device development. Areas of responsibility include develop business case, target connectivity profile, user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight, hardware and software integration, platform and app development. Extensive collaboration with internal and external partners.
The Sr. Engineer is expected to be knowledgeable of the overall device development program (i.e., Design Control, Change Control, Device Regulations, etc.) as well as electronics, software and networking engineering
Represent “smart” drug delivery system project(s) to external alliances as well as internal stakeholders
Guide the identification and assessment of new/emerging technologies with potential application to Shire products; assist in the realization of novel concepts, through prototyping and feasibility;
Be sought out by others as the expert in electromechanical “smart” delivery system project, digital product development, and combination product integration.
Ensure work and team activities are aligned with all relevant quality, regulatory, EHS, GLP, and GMP requirements.
Collaborate with internal partners (e.g., drug delivery and / or commercial) in user research efforts to uncover unmet user needs;
Collaborate with commercial and business stakeholders to drive business case development for project justification and approval by governing bodies;
Drive development of Target Connectivity Profile (TCP) for technology development projects;
Monitor market and competitive intelligence for impact on digital health strategy;
Identify and recommend potential partners/supplier and nurture relationships through contracting.
Manage technical activities of the smart delivery system project (e.g., external partners, complexity of electromechanical design, HW – SW development and integration, device interface).
Effectively execute role of representing the project(s) and effecting cross-functional integration on multi-disciplinary or cross functional teams.
Responsibilities (% of time):
50% (40-60%) Connected Device development – project execution
15% (10-20%) Development and maintenance of Shire Digital Health Platform
10% (5-20%) New Digital Technology exploration and assessment
10 (5 – 20%) Internal External alliance development
15 (10 – 20%) Project TDP, business case, and strategy development, User Research support
BS/BEng in relevant engineering or scientific area of study (typically, Electrical, Electronics, Information Technology, Computer engineering) with minimum seven (7) years’ experience in Medical Device or Combination products development.
MS in relevant engineering or scientific area of study (typically, Electrical, Electronics, Information Technology, Computer engineering) with minimum (5) years’ experience in Medical Device or combination product development.
Key Skills, Abilities, and Competencies
Experience with digital product development, IaaS, PaaS, SaaS
Experience with hardware and software integration
Experience with appropriate global regulations and standards - ISO 60601, Design Control - CFR 820.30, ISO 62304, ISO13485, ISO 14971, etc.
Experience in performing technology assessments, typically supporting due diligence activities.
Experience with the commercialization of medical devices, including combination products and connected drug delivery systems
Demonstrated expertise in digital health and connectivity.
Experience with technical leadership of internal and external teams and a demonstrated record of developing intellectual property
Able to work collaboratively
Good written and oral communication skills
Able to tailor communications for the audience
Understands how user needs drive requirements
Able to estimate activities and resources required to support a project
Travel of up to 25% may be required
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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.