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Principal Test Development Specialist
2 weeks ago
The Product Design Validation Engineer is responsible for executing design validation testing in support of product lifecycle management and new product development. This role involves developing and optimizing physical test methods and test fixtures to ensure the design verification and validation of medical device products.
Key Responsibilities- 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.
- 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.
- 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.
- 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).
A minimum of a Bachelor's degree in Engineering is required.
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&G, Hypothesis Testing
- Ability to solve problems, provide detailed insight and constructive criticism in complex situations, and foresee problems along with potential solutions.
- Disciplined and well-organized individual
- Excellent multi-tasking, analytical, communication, and prioritization skills
- Ability to work independently with minimal supervision as well as in a team environment
This 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.
