US-MA, Manager, eHealth and Connected Devices SR0019762-MZ
Summary: The Takeda Device Center of Excellence (DCoE) based in Lexington, Massachusetts allows Takeda 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. This technical team member will assist in identifying and delivering cross-functional Stand-alone and Combination Device Development efforts for smart devices and digital health projects. As a hands-on technical and digital health subject matter expert (SME), this person will assist in work efforts through feasibility, development, qualification, launch, and post-market life cycle phases of device development. Area of focus will include assisting with the target connectivity profile, user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, development oversight, design outputs, country localization, market launch, and post-market release management activities. Role includes extensive collaboration with internal and external partners. This individual is expected to be knowledgeable about the overall device development program (i.e., Design Control, Change Control, Device Regulations, etc.) and have software technical expertise to assist in the identification and assessment of new/emerging technologies with potential application to Takeda products. This individual is expected to demonstrate solid delivery of commitments while working within aggressive timelines. Responsibilities (% of time): 30% Connected Device Technology Planning / Assessment Provide input into the assessment of technologies as part of the long-range device plans, and products and services aligned with establish global connected health solutions for our products around the world. Identify and document scope and requirements for specific products (e.g., TDP). Develop stakeholder relationships to gather input into device product or platform projects. 40% Connected Device Technology Execution Responsible for assisting in device design inputs and design outputs; verification / validation testing, delivery, and post market support. Assist in delivery of device implementations on time and within scope Act as a subject matter technical expert in connected health industry standards including and not limited to mobile and web portal technology. Provide input to develop Takeda s eHealth technical platforms and capabilities. 20% Connected Device Post-Market Surveillance Activities Assist in responding to post market surveillance issues (e.g., product complaints, CAPAs, FCA, etc.). Assist in audit / inspection actions. Assist in documenting compliance requirements in changing regulatory and data privacy impacts to devices. 10% Vendor Engagement Assist in vendor management Assist in vendor assessments Develop and maintain inclusive collaboration across functions and across global and local region / country teams. Requirements: BS/BEng in information technology or relevant engineering of study (typically, Electrical, Electronics, Information Technology, Computer engineering,) with minimum five (5) years experience in product or software development and delivery. Demonstrated project results in commercial and / or digital technical delivery Direct experience in device environment and / or regulated validated system development Solid communication skills and ability Ability to identify issues and provide recommended solutions to resolve Technical application development skills a plus Experience in connected health technologies (device or software) a plus (e.g., software device, electronic health records, portals, etc.).
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.
Please visit our website at takedajobs.com