Job Overview
This role focuses on the development of new technologies within a quality system, ensuring compliance with regulatory requirements.
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Key Responsibilities
- Support the development and evolution of Design Control, Risk Management, and related systems for new product development technologies.
- Provide Design Assurance input to R&D project teams, understanding regulatory requirements and incorporating them into projects.
- Lead specification development and participate in generating Design Input/Output documents.
- Lead risk management activities for projects and design changes.
- Design, develop, and validate test methods to support development programs.
- Develop and maintain design verification and validation plans, protocols, and reports.
- Support R&D in preparing and delivering Design Reviews and checklists.
- Execute assigned project aspects.
- Mentor and support Design Assurance engineers.
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Requirements
- A degree in Engineering, Science, or related field.
- Over 5 years of relevant experience in the medical device or pharmaceutical industry.
- Understanding of ISO 13485, ISO 14971, and FDA QSRs.
- Familiarity with statistics, validation, and physical testing.
- Good communication and organizational skills.
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