Senior Design Quality Engineer

We are seeking an experienced Design Quality Engineer to join our growing Quality and Regulatory team. In this role, you will be responsible for supporting quality and regulatory activities throughout the new product development process, ensuring products are designed, developed, and launched in compliance with global medical device regulations and quality standards.

As a key member of the product development team, you will collaborate with Engineering, R&D, Manufacturing, Regulatory Affairs, suppliers, and customers to ensure quality is built into every stage of development. You will provide guidance on Design Controls, Risk Management, Critical-to-Quality (CTQ), and Design-for-Inspection (DFI) principles while helping maintain regulatory compliance for both contract-developed and company-owned products.

This position also plays a critical role in supporting Design History Files (DHFs), Technical Documentation, regulatory submissions, design transfers, supplier qualification, complaint investigations, CAPA activities, internal audits, and post-market surveillance. The ideal candidate is a self-starter with strong analytical skills, excellent communication abilities, and a passion for developing high-quality medical devices that meet customer and regulatory expectations.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field (or equivalent experience)
• 5+ years of Quality Engineering or Design Quality experience
• Experience supporting Design Controls within new product development
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR
• Strong problem-solving, organizational, and communication skills
• Ability to work cross-functionally in a fast-paced environment

• Medical device industry experience
• Experience with regulatory submissions for domestic and international markets
• Knowledge of Quality Management Systems (QMS)
• Experience with supplier quality, manufacturing process validation, and GD&T