US-MA, Senior Principal Engineer, Commercial Device Engineering SR0038163-MZ
This Sr. Principal Engineer is a technical leader who is a member of the Commercial Device Engineering (CDE) team accountable for leading the technical aspects of combination products that are on-market medical device products for drug delivery. These products enhance patient and medical professional experiences with Takeda s drugs delivery devices.
In particular, this technical leader has extensive experience in medical devices for drug delivery, including prefilled syringes, autoinjectors, reconstitution device for lyophilized drugs, and syringe-needle combinations for IV and subcutaneous delivery. This role will be responsible for on-market products with and will be a product owner involved in change controls, device product complaints, and regular review of DHF and post-market surveillance. The individual should have extensive medical device experience design and manufacturing. This role will also have direct reports overseeing other commercial device products and commercial device qualification.
This individual has extensive experience and is a subject matter expert (SME) in commercial device drug delivery products, risk assessments, device design control and device manufacturing with expertise in technical, regulatory and quality issues. Experience in pharmaceutical drug delivery applications is required. This role will interact with external Contract Manufacturing Organizations (CLOs) and Contract Manufacturing Organizations (CMOs).
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, Product Quality, Device Quality, along with Device Regulatory. Experience in Trackwise, or similar with ability to learn Trackwise, is required. Management of small teams for technical leadership and mentoring is required. The successful candidate will work in a team environment and establish strategic working relationships.
Responsibilities (% of time):
70%: Product and Technical Excellence:
20%: Team Leadership and Effectiveness:
10%: Supplier Relationship, Compliance, Quality and Operational Excellence:
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