Validation and Verification Engineering Role Overview
This key position plays a pivotal part in ensuring the integrity and reliability of medical device products throughout their lifecycle. The Validation and Verification Engineer will be responsible for executing comprehensive testing to validate product design inputs and ensure conformance to applicable Quality System and regulatory requirements.
Responsibilities:
* Develop new or optimize existing physical test methods and test fixtures to support the validation of new medical device products and changes to existing products.
* Draft engineering technical reports, test method work instructions or procedures, and test method validation related documents.
* Lead and execute test method validation (TMV), design verification, and test method transfer in support of product design verification or validation.
* Author design verification protocols to satisfy product design inputs/system requirements that meet applicable Quality System and regulatory requirements.
* Manage and track product configurations through design verification and validation.
* Perform hands-on and simulated testing for design verification and test method developments.
* Conduct functional and performance testing of products to ensure they meet required specifications.
* Identify and report out-of-specification results, data, and atypical/unexpected events that occur during testing activities and support associated investigations, impact assessments, and Root Cause Analysis (RCA).
Qualifications:
* Minimum of Bachelor's degree in Engineering.
* 3+ 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.
* Experience with executing Design Verification.
* Experience in statistical data analysis methods/tools, e.g., Gage R&R, Hypothesis Testing.
* Experience solving problems, providing detailed insight, and constructive criticism in complex situations and foreseeing problems along with potential solutions.
Key Skills:
* Disciplined and well-organized.
* Excellent multi-tasking, analytical, communication, and prioritization skills.
* Ability to work independently with minimal supervision as well as in a team environment.
Company Culture:
The company is an Equal Opportunity/Affirmative Action Employer, committed to fostering an inclusive culture that values diversity, equity, and inclusion.