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Job Role
The Verification and Validation Specialist is responsible for executing design verification and validation testing in support of product lifecycle management and new product development.
1. Develops new or optimizes existing physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products and changes to existing products.
2. Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents.
3. Leads/executes test method validation (TMV), design verification and test method transfer, in support of product design verification or validation
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)
Requirements:
* Minimum of Bachelor's degree in Engineering
* 3+ years of professional experience in the medical device, pharmaceutical or life sciences field
* Relevant Experience: Applied experience in developing and qualifying test systems and methods in support of product development and launch (IQ, OQ, Measurement Systems Analysis (MSA), etc.)
* Experience with executing Design Verification
* Experience in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing
A disciplined and well-organized individual with excellent multi-tasking, analytical, communication, and prioritization skills. Ability to work independently with minimal supervision as well as in a team environment.
This organization is committed to diversity and inclusion.