Shire Lead Device Engineer, Commercial Device Engineering in Lexington, Massachusetts

Summary:

This Lead Device Engineer is a technical leader who is a member of the Commercial Device Engineering Team that is accountable for technical aspects of the manufacturing of commercial drug delivery devices. These devices enhance patient and medical professional experiences with Shire’s products, particularly for immunology and hematology. In particular, this technical leader needs to have the medical device manufacturing experience including polymer / plastics processing and assembly methods, and working with outside vendors. 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. Some experience in rare disease applications such as immunology and/or hematology is desired. The successful candidate will establish strategic working relationships with several critical line functions within Technical Operations, including Quality and Regulatory Affairs. This role will have critical interactions with external Contract Manufacturing Organizations (CMOs). Experience in manufacturing processes and aspects of project manufacturing are required. This position liaises closely within Shire’s product teams, along with device development, Drug Product, Packaging and other areas of Supply Chain, Device Quality, Clinical and Regulatory functions.

Responsibilities (% of time):

70%

Product and Technical Excellence: Conduct technical oversight 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 guide technical aspects of risk management activities. Lead product project plans that within budget for stated activities.

15%

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-Medical Devices. Support Supply Assurance to deliver high quality device products. Collaborate on decisions in areas of medical device regulations, process validation, and shelf life stability

15%

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/6Sigma/Op Excellence) on CMO Suppliers, including internal and external technical meetings. Lead and support on-market product interactions and expansions in the most efficient way supporting Shire globalization.

Requirements:

  • Education: BS/MS required (MS preferred), with discipline in engineering (manufacturing, chemical, mechanical), with relevant experience or similar technical discipline. .

  • At least 10-12 years medical device experience with polymerc medical device experience

  • At least 8 years of experience in manufacturing of polymeric drug delivery and/ormedical device systems especially as biopharmaceutical combination device products, with preferred experience in reconstitution devices, IV sets and/or drug delivery devices.

Key Skills & Abilities:

• 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 various functions and expertly advise key stakeholders.

• Expertise in design history files with knowledge in design controls verification and validation, statistical methods and quality system requirements, and is required

• Ensured Compliance with appropriate device and combination product regulations and Shire policies

• Technical leadership for pre-commercial and commercialized drug delivery system devices and combination products through technology transfer using operational excellence methodology. Experience in QbD,6Sigma and/or Operational Excellence is highly preferred.

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Equal Employment Opportunity

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, 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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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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.