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  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

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Sr. Engineer II

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Job ID SR0050324 Date posted 06/29/2020 Location Lexington, Massachusetts

Summary:

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

In particular, this technical leader has significant experience in medical devices for drug delivery, including reconstitution devices or their subcomponents, and injection devices (prefilled syringes, autoinjectors) or their subcomponents, especially as these are used for lyophilized drugs. These devices may be used for intravenous or  subcutaneous drug delivery. This key technical role will be responsible for or give input for change controls (proces, material, etc.), manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role may interact with external Contract Manufacturing Organizations (CLOs) and Contract Manufacturing Organizations (CMOs).

This individual will become a subject matter expert (SME) in commercial device drug delivery products, and has experience in risk assessments, device design control and device manufacturing with respect to technical, regulatory and quality issues. The individual should have significant medical device experience in design and manufacturing.  Experience in drug delivery is highly preferred with experience in bio/pharmaceutical industry highly preferred.  

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, with Product Quality; Device Quality; Device Regulatory. Experience in QMS such as Trackwise, or similar, with ability to learn details Trackwise 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 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 defined activities

20%:  Team Leadership and Effectiveness: Support 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: Support 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 Takeda globalization.

Requirements:

Education: BS degree in an engineering discipline and minimum 7 years of experience, MS degree with minimum 6 years of experience, or PhD with minimum 4 years of experience, with focused disciplines in engineering such as chemical, mechanical, biomedical, materials, or similar credentials.

Key Skills & Abilities:

  • The role will lead and capably deliver:
    Subject Matter Expertise in medical devices, particularly drug delivery systems, with technical leadership to manage drug delivery device commercialized products such as vial reconstitution devices or injectable devices (prefilled pens, syringes, autoinjectors, etc.).
  • Experience in medical device LCM: change controls, device complaint investigations and post-market surveillance
  • Experience and understanding of drug delivery devices and manufacturing processes
  • Knowledge of industry regulatory and compliance standards for complaint analyses in US, EU and ROW.
  • Technical leadership for high performing teams, with strong ability to meet timelines, work effectively cross functionally and expertly advise key stakeholders.
  • Knowledge in design controls and quality system requirements
  • Ensured Compliance with appropriate device and combination product regulations and Takeda         policies
  • Knowledge, Training and/or certification in six-sigma and lean methodologies

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

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.

Job ID SR0050324

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