Design Quality Engineer – Catheters

This role will be responsible for ensuring the new products and design changes to existing products meet regulatory and quality requirements throughout the design and development process. This will be accomplished through collaboration with cross-functional teams performing verification and validation, process development activities, product risk management requirements and product reliability activities. The role also involves leading the sustainability efforts in production to ensure product compliance is maintained and ongoing process improvements are implemented.

Your Responsibilities Include

• Lead and support new product development design control deliverables for Catheter/Disposable or Software/Hardware products.
• Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
• Lead Risk manag...