Shire Principal Device Development Packaging Engineer in Lexington, Massachusetts

Summary:

Accountable and responsible for product packaging design for medical devices and combination products using a combination of principles of packaging technology, design engineering, innovation and human interface engineering. This position will provide novel conceptual and innovative new packaging designs for all device development at Shire, This role will also be involved in the concept development of secondary packaging for devices, and will be working very closely with the device engineering team, the human factors engineering team, device product team and commercial/marketing partners to develop and tests design concepts. The candidate will also work closely with the packaging engineering group to coordinate final commercial device packaging and support product and device registration and commercialization globally.

Ability to explore user interface between product, device and patients, use packaging design Additional responsibilities may include participating in package trial runs, project start-ups (FATs/SATs), and resolving issues to support cross functional team. This position will support the team to reduce errors and enhance treatment to provide positive outcomes and reduce failure modes, assess and develop patient environment and analyze critical inputs and outputs and partnering with stakeholders is essential to this role. Ensures proper support for multiple programs reflecting business priorities. Ensures proper documentation to support DHF. Supports testing and validation activities.

Responsibilties (% of time):

40%

  • Develop innovative new device packaging concepts, Manage packaging design activities by designing and developing, secondary packaging solution to offer to stakeholders.

  • Lead, manage and execute all aspects of a device secondary packaging project delivering early phase evaluation to stakeholders. Accountable for delivering on specific performance indicators, including but not limited to:

  • successful concept design solutions,

  • visualization of concepts and prototyping as appropriate

  • successful human factors studies,

  • realistic and manufacturable design concepts to meet commercialization objectives

  • May be the Process Owner and /or the Execution Lead, for one or more processes, including but not limited to:

  • New Device Packaging Technology Acquisition

  • New Device Package Introduction

  • Combination Product and Device Packaging

  • Packaging & Art-Work Specifications process including device instructions for use

  • Packaging Process Development

  • Includes demonstration and starter kits

  • Ensures proper level of documentation and covers packaging related DHF aspects

30%

  • Will work with internal stakeholders to create or enhance device packaging capabilities to deliver the needed quality required by our patients.

  • Will partner with packaging engineering group to ensure quality in product packaging and drive elimination of customer complaints relating to commercial packaging.

  • Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.

  • Monitors packaging related standards and norms

15%

  • Serve as an early concept Package Engineer to the Device Product Technical Teams

  • Support protocols development for the feasibility testing

  • Support and lead labeling change process by evaluating the impact on packaging material and on the packing operations.

15%

  • Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects (focus on concept development and prototyping).

  • To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.

  • Represents device development and external manufacturing on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions.

  • Investigate new sources and make recommendations on packaging materials and support material change and implementation.

  • Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.

Requirements:

  • Requires a Bachelor’s degree in a scientific/technical discipline with a minimum of 8 years related experience. Applies expert knowledge of scientific/technical principles & concepts in managing technical programs such as:

  • Technology acquisition

  • Equipment qualification

  • Package design development for secondary and tertiary packaging system

  • Technology transfer

  • Qualification of packaging components

  • Experience in global product launches and the associated CMC regulatory requirements.

  • Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred.

  • Demonstrated ability to simultaneously manage multiple projects of variable complexity.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.