The Shire Device Center of Excellence (DCoE) based in Lexington, Massachusetts allows Shire to explore how next generation therapeutics, emerging technologies and new care models can improve patient health. Our team shares a passion for challenging conventional wisdom and creating an environment that embraces the risk-reward aspects of developing breakthrough concepts. The DCoE offers a start-up environment with large company support. The DCoE works closely with research and development, commercial, device and drug product teams, and key external partners to drive early stage device/delivery system initiatives from concept to launch.
As a leader in eHealth and Connected Medical Devices, this role will be responsible for driving the development of business cases and providing innovative technical solutions to meet R&D and / or commercial priorities. The role necessitates strong leadership to translate the science of Shire’s product portfolio (both drug and device) into software devices solutions that are critical to Shire’s strategy. This role may be dedicated to specific therapeutic are or cross-therapeutic areas depending on the demand. This role will drive thought leadership in strategies across connected health platforms and Software Medical Device (e.g., test and risk assessments strategies, and hardware and software integration, platform and app development vision, etc.) and be responsible for all aspects of life-cycle management. Strong delivery execution within aggressive timelines and within a changing eHealth environment is expected. The role requires leadership interaction across multiple different functions (e.g., regulatory, quality, medical affairs, commercial, research and development, biostatisticians, technology teams, data privacy, compliance, etc.). Role includes extensive collaboration with internal and external partners. This role requires strong communication skills and the ability to take complex or ambiguous ideas and synthesize into clear and concise action. This role performs a key role in audit / inspections and requires adherence to Shire’s compliance policies and procedures.
Responsibilities (% of time):
Connected Device Technology Planning / Assessment
- Provide input into the development of long-range device plans, and products and services aligned with establish global connected health solutions for our products around the world.
- Provide input into Business Case and ROI (scope, timing, functionality, cost for original and revisions) with support from IT Application Areas (architecture, infrastructure, services, IT security / compliance) and cross-functional owners (e.g., Commercial, Marketing, Medical Affairs, Regulatory, Quality, Legal / Data privacy, etc.).
- Responsible for maintaining commercial stakeholder relationships to align connected device priorities with commercial device launch strategies.
Connected Device Technology Execution
- Responsible to document business requirements, develop functional designs, build, verification / validation test, deliver, and support solutions to develop next-generation device connected care models.
- Accountable to ensure connected device implementations meet defined business requirements and follow the appropriate compliance requirements (e.g. Design Control).
- Ensure successful device implementations on time and within budget.
- Escalation point for project and business issues for assigned product or projects.
- Subject matter technical expert in connected health industry standards including and not limited to mobile and web portal technology.
- Provide input to develop Shire’s eHealth technical platforms and capabilities.
- Subject matter technical expert in connected health industry trends and standards.
Connected Device Post-Market Surveillance Activities
- Responsible for responding to post market surveillance issues (e.g., product complaints, CAPAs, FCA, etc.).
- Responsible for audit / inspection actions.
- Responsible for working with compliance functions to understand changing regulatory and data privacy impacts to devices.
- Responsible for estimating new product efforts at planning phase.
- Responsible for managing budgets and monitoring spend for assigned products.
- Manage IT investment portfolio for assigned product or project areas.
People Development / Vendor Management
- Drive innovation and challenge conventional thinking in the delivery of SaMD technologies.
- Develop and maintain inclusive collaboration across functions and across global and local region / country teams.
BS/BEng in information technology or relevant engineering of study (typically, Electrical, Electronics, Information Technology, Computer engineering,) with minimum ten (10) years’ experience in product or software development and delivery.
- 10+ years of technical and functional experience in the healthcare industry
- Demonstrated project results in commercial and / or digital technical delivery
- Direct experience in eHealth or Connect Health environment and / or regulated validated system development
- Demonstrated financial discipline in estimating technical efforts and managing budgets of $3-$5M
- Experience in large complex scale or multiple project technical implementations required
- Management experience in supervising 10+ resources
- Strong communication skills and ability to articulate complex scenarios
- Technical application development skills a plus
- Experience in connected health technologies a plus (e.g., software device, electronic health records, portals, etc.).
Key Skills & Competencies:
- Experience with appropriate global regulations and standards – ISO60601, Design Control – CFR 820.30, ISO62304, ISO13485, ISO14971, etc.
- Able to scope and define device inputs for new device platforms.
- Ability to work teams to develop new device assets and create asset roadmap.
- Able to manage vendor teams.
- Able to work in validated device environment with focus on compliance.
- Able to work collaboratively.
- Good written and oral communication skills.
Req ID: R0020069