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Shire Principal Engineer, Commercial Device Lead in Lexington, Massachusetts
This 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 Shire’s 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 Shire’s 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):
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.
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
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.
Lead and support on-market product interactions and expansions in the most efficient way supporting Shire globalization.
• Education: BS/MS required (MS/PhD preferred), with discipline in engineering (chemical, mechanical, biomedical, materials), with relevant experience, or similar.
• At least 6 (w PhD) or 9 (w MS) or 10+ years w BS medical device experience with biopharmaceutical industry experience
• At least 4 years of drug delivery systems and/or biopharmaceutical combination device experience, with specific experience in drug delivery devices: lyophilized drug reconstitution, IV sets, and/or ancillary devices.
Key Skills & Competencies:
• Subject Matter Expertise in manufacturing of drug delivery systems with technical leadership to manage tech transfer for commercialized drug delivery system devices and combination products such as vial reconstitution devices, IV sets and/or ancillary devices
• Excellent understanding of polymeric medical device manufacturing processes via molding and assembly
• Lead of technical support for improvements at CMO’s and/or line extensions
• Knowledge of current industry regulatory and compliance trends related to commercial drug delivery devices
• Project leadership and participation in high performing teams with strong ability to meet timelines, work effectively cross functionally and expertly advise key stakeholders.
• Expertise in file remediations with knowledge in design controls, validation, regulatory requirements and quality system requirements
• Ensured Compliance with appropriate device and combination product regulations and Shire policies
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.