Senior Engineer, R&D Verification and Validation

Overview

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

Responsibilities

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.
• Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents
• 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 System (QS) and regulatory requirements
• Manages and tracks product configurations through design verification and validation, including Hardware / Software / Firmware version tracking, to allow for determination of impact due to configuration changes
• Performs hands-on and simulated testing for design verification and test method developments
• Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications
• Interacts with external development partners and equipment suppliers, Operations, Quality, and IT / Infrastructure groups to achieve design verification and validation deliverables
• Supports the R&D team in data review, analysis, and interpretation. Identifies and reports out of specification results, data, and atypical / unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)

Minimum Qualifications :

Desired Qualifications :

Knowledge, Skills and Abilities :

For certain roles at embecta, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with Client's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

embecta is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA MA - Andover

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