Posted to MedZilla on 8/17/2019


Takeda Pharmaceuticals

US-MA, Principal Design Quality Engineer (DQE) SR0036817-MZ


 
 

Primary Duties

The Principal Design Quality Engineer will provide technical quality leadership and support for Takeda s medical device and combination product development efforts throughout clinical development, product registration, and commercialization. This DQE team member will work collaboratively with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes. This DQE team member will ensure Takeda develops medical devices and combination products in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI).

Responsibilities

75%: Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Lead design control gap assessments, remediation planning, and remediation execution as required.

10%: Partner with external design/development and/or manufacturing partners on development activities, including risk management, quality planning, and design transfer.

10%: Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle.

5%: Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards.

Education and Experience Requirements

  • BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred
  • 10+ years of device product development and/or quality engineering, including a minimum of 4 in design quality, required
  • Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820, ISO 13485, ISO 14971), as well as other applicable standards required
  • Experience in leading design quality activities and influencing senior management required
  • Experience with statistical and six sigma methods required, and Black Belt preferred
  • Experience with risk management processes and tools required
  • Experience with sustaining engineering preferred
  • Experience with Class II or III medical devices required, and experience with implantable devices preferred
  • Experience working with external contract partners for design, development, manufacturing, and/or testing required

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.


Please visit our website at takedajobs.com

 
 


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