Senior Validation Engineer
Position Overview:
As a Senior Validation Engineer, you will play a critical role in developing and optimizing physical test methods and test fixtures to support the design verification, validation, and commercialization of new medical device products. You will work closely with cross-functional teams to ensure that all design verification and validation activities meet the necessary regulatory and quality standards.
Key Responsibilities:
- Prepare engineering reports, create test method work instructions, and develop documentation related to test method validation.
- Lead and manage TMV, design verification, and the transfer of test methods to ensure successful product design validation.
- Develop design verification protocols to ensure alignment with product design requirements/systems, while adhering to QS and regulatory standards.
- Conduct both practical and simulated tests for design verification and the development of new test methods.
- Execute functional and performance testing to verify that products and their components meet established specifications.
- Work closely with external development partners, equipment vendors, and cross-functional teams (Operations, Quality, IT/Infrastructure) to ensure design verification and validation objectives are met.
- Assist the R&D team in reviewing, analyzing, and interpreting data; identify and report any out-of-specification results or unusual occurrences during testing, while supporting investigations and Root Cause Analysis (RCA).
- Ensure that test methods and equipment are validated and compliant with company requirements.
Qualifications:
- Minimum of a Bachelor's degree in Engineering, or a related field.
- 5 years of professional experience in the medical device or life sciences industry.
- Applied experience in developing and qualifying test systems and methods in support of product development and launch (IQ, OQ, MSA)
- Proficiency in statistical data analysis methods/tools, such as Gage R&R, Hypothesis Testing, Tolerance Interval Analysis, Acceptance Sampling, etc.
- Hands-on experience in managing product changes using a structured, phase-gated development process within a regulated environment.
- Working knowledge of applicable medical device regulatory standards.
Join a dynamic and forward-thinking team dedicated to advancing patient outcomes, where you'll work with cutting-edge medical device technology, contribute to life-changing innovations, and enjoy competitive compensation, comprehensive benefits, and ample opportunities for professional growth and career advancement.
