Senior Engineer, R&D - Verification and Validation
About the Role:
The Senior Engineer, R&D - Verification and Validation is accountable for the execution of design verification and design validation testing in support of product lifecycle management and new product development.
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.
* 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.
Requirements:
* Minimum of Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering or related field.
* 8+ years of professional experience in the medical device, pharmaceutical or life sciences field.
* 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 and/or Design Validation on a mechanical or electromechanical medical device.
* Demonstrable proficiency in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing, Tolerance Interval Analysis, Acceptance Sampling, etc. using Minitab, SAS or similar data analysis packages.
* Practical experience with implementing product changes through a structured, phase-gated product development process within a regulated framework.
* Working knowledge of applicable medical device regulatory standards.