Posted to MedZilla on 7/17/2019

Takeda Pharmaceuticals

US-MA, Senior Principal Engineer, Commercial Device Engineering SR0038163-MZ



This Sr. Principal Engineer is a technical leader who is a member of the Commercial Device Engineering (CDE) team accountable for leading the technical aspects of combination products that are on-market medical device products for drug delivery. These products enhance patient and medical professional experiences with Takeda s drugs delivery devices.

In particular, this technical leader has extensive experience in medical devices for drug delivery, including prefilled syringes, autoinjectors, reconstitution device for lyophilized drugs, and syringe-needle combinations for IV and subcutaneous delivery. This role will be responsible for on-market products with and will be a product owner involved in change controls, device product complaints, and regular review of DHF and post-market surveillance. The individual should have extensive medical device experience design and manufacturing. This role will also have direct reports overseeing other commercial device products and commercial device qualification.

This individual has extensive experience and is a subject matter expert (SME) in commercial device drug delivery products, risk assessments, device design control and device manufacturing with expertise in technical, regulatory and quality issues. Experience in pharmaceutical drug delivery applications is required. This role will interact with external Contract Manufacturing Organizations (CLOs) and Contract Manufacturing Organizations (CMOs).

This CDE position is within Takeda s Medical Device Center of Excellence (MD CoE) and will have cross-functional interaction with Development Device Engineering for Device Tech Transfer, Product Quality, Device Quality, along with Device Regulatory. Experience in Trackwise, or similar with ability to learn Trackwise, is required. Management of small teams for technical leadership and mentoring is required. The successful candidate will work in a team environment and establish strategic working relationships.

Responsibilities (% of time):

70%: Product and Technical Excellence:

  • Provide overall direction and technical oversight of commercial drug delivery devices.
  • Conduct technical investigations, analyze technical aspects related to the manufacturing processes and/or commercial expansion, oversight of commercial device qualification processes, coordinate tech transfer of verification and validations related to technology transfer of new drug delivery devices, and solve technical issues related to commercial products.
  • Provide input to change controls, device complaints and post-market surveillance reports.
  • Lead gap assessments / remediations as needed and guide technical aspects of risk management activities. Lead products projects within budget for stated activities

20%: Team Leadership and Effectiveness:

  • Facilitate the evolution of the commercial device engineering function through technical initiatives in alignment with product teams and Technical Operations- Process Development and Supply Chain.
  • Deliver competence and high-quality decisions in areas of medical device regulations, process validation, and shelf life stability

10%: Supplier Relationship, Compliance, Quality and Operational Excellence:

  • Drive operational initiatives within a culture committed to operational excellence. Support and/or lead Continuous Improvement initiatives (including Lean Sigma/Op Excellence) at CLO Suppliers, including leading regular technical meetings.
  • Lead and support on-market product interactions and expansions in the most efficient way supporting Shire globalization.

Education/Experience Requirements:

  • Education: BS/MS required (MS/PhD preferred), with discipline in engineering (chemical, mechanical, biomedical, materials), with relevant experience, or similar.
  • At least 10-12 years medical device experience, with minimum 6 years biopharmaceutical industry experience
  • At least 4 years of management experience, preferably in medical device and/or biopharmaceutical combination products.

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.

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Reasonable Accommodations

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.

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