Shire Sr. Device Design Quality Engineer in Lexington, Massachusetts
The Senior Device Design Quality Engineer will provide technical quality leadership and support for Shire’s medical device and combination product development efforts throughout clinical development, product registration, and commercialization. This DQE will support class 2 electromechanical and reconstitution devices, and other drug delivery devices as required. This DQE team member will work collaboratively with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes. This DQE team member will ensure Shire develops medical devices and combination products in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI).
85%: Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Partner with and provide oversight of external design/development and manufacturing partners on development activities. Lead design control gap assessments and remediation as required.
10%: Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle.
5%: Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards.
Education and Experience Requirements
Minimum of a BS in engineering or equivalent technical discipline required , and advanced degree preferred
6+ years of device and/or combination product development within a medical device or biotech / pharmaceutical organization required, including minimum of 2 in design quality, required
Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820, ISO 13485, ISO 14971), as well as other applicable standards required
Experience in leading design quality activities required
Experience with statistical and six sigma methods required , and Green/Black Belt preferred
Experience with risk management processes and tools required
Experience with sustaining engineering preferred
Experience with electromechanical device development required
Experience working with external contract partners for design, development, manufacturing, and/or testing required
Ability to travel within the US and internationally 10% required
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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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.