US-MA, Head of Injection Systems SR0039588-MZ
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.
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
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