US-MA, Senior Engineer II SR0038332-MZ
This Sr. Engineer II is a technical leader who is a member of the Commercial Device Engineering (CDE) team accountable for leading the technical aspects of medical device and combination products that are on-market products for drug delivery. These products enhance patient and medical professional experiences with Takeda s medicinal drug products.
In particular, this technical leader has significant experience in medical devices for drug delivery, including reconstitution devices or their subcomponents, and injection devices (prefilled syringes, autoinjectors) or their subcomponents, especially as these are used for lyophilized drugs. These devices may be used for intravenous or subcutaneous drug delivery. This key technical role will be responsible for or give input for change controls (proces, material, etc.), manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role may interact with external Contract Manufacturing Organizations (CLOs) and Contract Manufacturing Organizations (CMOs).
This individual will become a subject matter expert (SME) in commercial device drug delivery products, and has experience in risk assessments, device design control and device manufacturing with respect to technical, regulatory and quality issues. The individual should have significant medical device experience in design and manufacturing. Experience in drug delivery is highly preferred with experience in bio/pharmaceutical industry highly preferred.
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, with Product Quality; Device Quality; Device Regulatory. Experience in QMS such as Trackwise, or similar, with ability to learn details Trackwise 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:
Education: BS degree in an engineering discipline and minimum 7 years of experience, MS degree with minimum 6 years of experience, or PhD with minimum 4 years of experience, with focused disciplines in engineering such as chemical, mechanical, biomedical, materials, or similar credentials.
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