A Senior Engineer in the Commercial Device Engineering (CDE) group is a technical leader who is a member of product teams. These teams are accountable for leading the technical aspects of commercialized devices and combination products that enhance patient and medical professional experiences with Shire’s drug delivery devices.
In particular, this technical leader needs to have the ability to grow the knowledge in reconstitution devices, IV sets and drug delivery devices.
This individual will aspire to become a subject matter expert (SME) in technical, regulatory and quality issues related to commercial devices and drug delivery. Some experience in rare disease applications is desired. The successful candidate will work in a matrix environment and establish strategic working relationships with several critical line functions within Technical Operations, as well as Device Quality. This role will also have some interactions with external Contract Manufacturing Organizations (CMOs). Experience in manufacturing processes is highly preferred.
This position may liaise with other Shire departments including device development, Drug Product, Packaging and other areas of Supply Chain, Device Quality, Clinical and Regulatory functions; thus, solid communication skills are required.Responsibilties (% of time):80%
Product and Technical Excellence: Conduct technical investigations process transfer validation studies for device manufacturing needs of commercial drug delivery device products. Foremost this includes technology transfer, manufacturing capacity / line extensions, change controls and potential support for product complaints. Keen leadership and oversight of verification and validation protocols with strong statistical sampling justifications are especially required for commercial product technology transfer and operational excellence.
Support technical aspects of risk management activities, and product project plans within timelines for stated activities.
Team Leadership and Effectiveness: Support the evolution of the commercial devices function through technical initiatives in alignment with Technical Operations and Process Development.
Deliver competent and high quality technical expertise in areas of medical device process validation and manufacturing.
Supplier Manufacturing, Quality and Operational Excellence: Support operational initiatives within a culture committed to operational excellence.
Support the capacity expansion, launch of new products and expansion into new territories in the most efficient way supporting Shire globalization.
Drive Continuous Improvement initiatives (including Lean Sigma/Op Excellence).
Education & Experience Requirements
• Education: BS/MS engineering degree (MS preferred), with disciplines including Mechanical, Chemical, Materials, Biomedical or other relevant Engineering degrees. Biopharmaceutical and / or medical device experience required.
• At least 5-7 years medical device experience preferably with biopharmaceutical industry experience. Experience in drug delivery systems and/or combination devices experience, with specific knowledge in injection systems and kits, is preferred.
Location/Region: Lexington, MA