Senior Engineer, Connected Devices and Digital Health

Responsibilities The Takeda Device Center of Excellence(DCoE) in Lexington, Massachusetts allows Takeda 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 Takeda'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 Position Responsibilities: 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 Takeda 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 Takeda 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 Requirements: 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. or 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 Self-starter Travel Travel of up to 25% may be Job ID SR0022136
Salary Range: NA
Minimum Qualification
5 - 7 years

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.