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Job ID SR0039588 Date posted 07/24/2019 Location Lexington, Massachusetts
The Head of Device Development for injection Systems will lead Takedas 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.
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
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 Takedas 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.
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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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-###-#### and let us know the nature of your request and your contact information.
Job ID SR0039588
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Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.
At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.
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