Principal Technology Development Specialist
2 weeks ago
We are seeking a Senior Design Assurance Engineer to join our team. Reporting to the Design Assurance Manager, the successful candidate will focus on the development of new technologies.
About the Role- The selected candidate will work within the quality system, ensuring compliance with relevant regulations and standards.
- They will support the development and evolution of Design Control, Risk Management, and related systems for new product development technologies.
- Design Assurance input will be provided to R&D project teams, understanding regulatory requirements and incorporating them into projects.
Key responsibilities include:
- Leading specification development and participating in generating Design Input/Output documents.
- Leading risk management activities for projects and design changes.
- Designing, developing, and validating test methods to support development programs.
- Maintaining design verification and validation plans, protocols, and reports.
- Supporting R&D in preparing and delivering Design Reviews and checklists.
- Executing assigned project aspects.
- A degree in Engineering, Science, or a related field.
- Over 5 years of relevant experience in the medical device or pharmaceutical industry, preferably with Stent and Stent Coating technology.
- Understanding of ISO 13485, ISO 14971, and FDA QSRs.
- Familiarity with statistics, validation, and physical testing.
This is an exciting opportunity for a motivated individual to develop their skills and contribute to the success of our organization.
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