Posted to MedZilla on 9/20/2019


Takeda Pharmaceuticals

US-MA, Head of Injection Systems SR0039588-MZ


 
 

Primary Role

The Head of Device Development for injection Systems will lead Takeda s cross functional Combination Device Development efforts specific to prefilled syringes and auto-injectors.

The ideal candidate will be an experienced Manager that can guide a team of technical engineers. The candidate is considered a device subject matter expert (SME), and will provide project and engineering leadership in device and/or system identification, feasibility, development, qualification and launch readiness for prefilled syringe and auto-injector systems.

Area of focus will be on leading a team and where needed providing guidance regarding identification of user needs, product requirements and specification development, feasibility test development, design verification and validation testing, risk assessments, DHF creation, general project team technical support, and extensive collaboration with both internal stakeholders and external development partners.

Responsibilities

30%: Provide functional leadership for the injection device team (about 10 people)

20%: Oversee the project execution in compliance with design control SOP. Oversee all technical aspects of the development process including pertinent DHF deliverables, statistically ound design verification protocols/reports, design validation activities, and support with Human Factors studies.

15%: Provide project and technical leadership to cross functional teams for projects through clinical development, product registration and launch-readiness.

15%: Ensure team meets current standards on Design Control and DHF expectations, in accordance with regulations.

15%: Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.

5%: Support the optimization of design control elements to comply with medical device regulations. Lead or assist in deviation, complaint and failure investigations.

Education & Experience Requirements

  • More than 15 years experience in the field of medical device or combination product development and commercialization is required. Prefilled-syringe and or auto-injector experience is preferred.
  • A Bachelor s of Science Degree in Engineering required, a Master s of Science Degree preferred.
  • Minimum of 8 years cross functional leading teams and projects.
  • Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820), ISO13485, and ISO14791 requirements.
  • Proven track record of developing and gaining regulatory approval of drug delivery systems a plus.
  • Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..).
  • Strong hands on technical leadership skills with a track record of delivering products to market.
  • Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences is expected.
  • DFSS certification is desirable.
  • Prior experience leading projects that include managing external design, development, and manufacturing partners.

Other Requirements

Some domestic and international travel may be necessary

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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