Principal Engineer Reconsititution Devices

Posted on Dec 14, 2018 by Affinity Executive Search

Lexington, MA 02420
Education
Immediate Start
Annual Salary
Full-Time
Principal Engineer is a technical leader who is a member of the Commercial Device Engineering team accountable for leading the technical aspects of combination products that are on-market device products. These products enhance patient and medical professional experiences with drugs via delivery devices. In particular, this technical leader needs to have the medical device manufacturing experience including polymer / plastics processing and assembly methods, working with outside vendors and addressing technical issues including product complaints. The ideal candidate will have the ability to grow the knowledge in reconstitution devices, IV sets and drug delivery devices. This individual has extensive experience and is a subject matter expert (SME) in device design control, design and manufacturing, change management, medical devices with expertise in technical, regulatory and quality issues. Experience in rare or specialty disease applications is preferred. This position liaises closely within Technical Operations product teams, including Device Development, Quality, Drug Product, Package Development and within other areas such as Supply Chain. The successful candidate will work in a team environment and establish strategic working relationships outside of Technical Operations, such as Clinical and Regulatory Affairs. This role will have interaction with external Contract Manufacturing Organizations.Responsibilities (% of time): 70%Product and Technical Excellence: Conduct technical investigations of commercial medical device manufacturing for technology transfer, quality robustness, commercial expansion, verification / validation protocols / reports and technical investigations. Have experience to support processes for regulatory filings, product complaints, change controls and other device quality related processes.Lead gap assessments / remediations as needed, and lead technical aspects of risk management activities with quality for compliance. Support device product projects within budget for stated activities. 20%Team Leadership and Effectiveness: Facilitate the evolution of the commercial device engineering function through technical initiatives in alignment with product teams and Technical Operations- Process Development and Supply Chain.Deliver competence and high quality decisions in areas of medical device regulations, process validation, and shelf life stability 10%Supplier Relationship, Compliance, Quality and Operational Excellence: Drive operational initiatives within a culture committed to operational excellence. Support and/or lead Continuous Improvement initiatives (including Lean Sigma/Op Excellence) on CMO Suppliers, including leading regular technical meetings.

Reference: 597238883

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