Job Details:

Senior Quality Engineer w/ Novo Nordisk Research & Development US, Inc. in Lexington, MA.

Conduct quality oversight and support for product development teams, and development and maintenance of the Quality Management System (QMS) to support the regulated development of devices intended to prepare and administer doses of cellular medicines. Work within cross-functional teams to develop new medical device designs to solve a wide range of technical challenges. Develop devices considered combination products in conjunction with cellular medicines and related formulations. Write, review and approve protocols, perform analyses and write, review and approve reports compliant with Design Controls as part of formal design verification & validation. Develop and support verification and validation activities to ensure that product designs meet the customer needs, including bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate. Demonstrate a thorough knowledge of medical device development compliant with requirements for Europe (MDR, ISO 13485) and the USA (QSR / 21 CFR Part 820).

Requires a Master’s degree or foreign equivalent in Chemical Engineering or a related field and minimum two (2) years of experience (or alternatively a Bachelor’s degree or foreign equivalent in Chemical Engineering or a related field and minimum 5 years of experience) working with quality standards. Experience must include: Identify and optimize any design/process requirements change in existing product per latest medical device standards and regulations; Support design test and inspection method development and perform method validation activities; Work with cross functional teams for certification/re-certification of Class III medical device products and Author and review general safety and performance requirements (GSPRs) checklists for CRM products submitted under EUMDR.

How to Apply:

Email resume to Novo Nordisk Research & Development US, Inc. at same@novonordisk.com, Ref# SQEMA0414