What are the responsibilities and job description for the Senior Design Verification Lead position at Katalyst CRO?
Responsibilitie
- Act as the primary liaison to the organization for all design verification activities.
- serving as the domain expert on verification processes, standards, and statistical methods.
- Oversee the entire design verification process, ensuring alignment with company goals and FDA requirements.
- Provide strategic guidance for test method development, fixtures, and equipment validation.
- Lead critical investigations, defect resolution processes, and risk management activities.
- Influence organizational practices by driving continuous improvement in design verification methodologies.
- Mentor engineers across all levels and provide technical training as needed.
- 10 years of experience in design verification, with extensive medical device expertise.
- Proven track record as a technical leader and subject matter expert.
- Strong communication skills to interface with regulatory bodies and cross-functional teams.
- Advanced knowledge of statistical techniques, including hypothesis testing and variance analysis.
