Product Validation Lead
7 days ago
About Gentuity
Gentuity is a pioneering medical technology company focused on the research, development, and commercialization of vascular imaging devices.
This exciting opportunity provides a unique chance to contribute to innovative medical products that can make a significant impact on patient care.
Job Overview
The ideal candidate will be responsible for ensuring new products and design changes meet regulatory and quality standards throughout the development process.
This will involve working closely with cross-functional teams to perform verification, validation, risk management, and reliability activities.
Key Responsibilities
- Lead and support new product development design control deliverables for catheter, software, and hardware products.
- Develop and implement risk management strategies, including FMEAs, hazard analysis, and other risk management file documents.
- Oversee the maintenance and auditing of Design History Files.
- Collaborate with cross-functional teams to develop and execute Process/Design Validation/Verification activities.
- Provide quality and compliance support during regulatory audits and responses to government agency questions.
- Lead CAPA efforts and apply sound problem-solving methodologies.
- Review and approve manufacturing verification and validation protocols and test reports.
- Contribute to design control and review processes, including quality planning.
Requirements
- Bachelor's degree in a science, engineering, or related technical discipline.
- At least 8 years of experience with engineering and development of catheter and/or electro-mechanical devices.
- Strong knowledge of medical device design controls and risk management regulations.
- Proficiency in US and international regulations.
- Experience with catheter products and/or capital equipment or optical imaging technology preferred.
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