Senior Engineer, R&D - Verification and Validation

embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and Twitter. 

The Senior Engineer, R&D – Verification and Validation, is accountable for the planning and execution of design verification or design validation testing in support of new product development as well as sustaining design projects, for complex electromechanical medical devices. Reporting up to the Associate Director, R&D – Verification and Validation, the successful candidate brings prior electromechanical medical device R&D or design quality assurance experience, to facilitate successful regulatory submissions of candidate product designs, in the US as well as other geographical regions.

Responsibilities include but not limited to the following:

• Develops new or optimizes existing physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products.
• Provides inputs on design input requirements to ensure that they are unambiguous, non-conflicting and testable and crafts rationales or justifications to support applicability of the requirements to the design project.
• Assists with planning for test method validations (TMV) and drafts TMV protocols, utilizing relevant statistical principles like Gage R&R, ANOVA analysis, etc.
• Leads/executes test method validation (TMV), design verification and test method transfer, in support of product design verification or validation.
• Authors design verification protocols to satisfy product design inputs/system requirements, that satisfy applicable Quality S