Engineering Manager, Design Quality

Position Summary

Lead innovation in medical technology. As an Engineering Manager for Design Quality, you’ll play a pivotal role in shaping best-in-class product development outcomes. You’ll lead a talented technical team, influence design strategies, and ensure compliance with global standards, all while driving solutions that improve patient care. If you’re passionate about leadership, product development, and making a measurable impact, this is your opportunity.

What You Will Do

• Lead and develop a Design Quality team supporting New Product Development (NPD) to deliver compliant, high-quality products.
• Drive achievement of business metrics, including product quality measures, schedule attainment, and timely resolution of NC/CAPA actions.
• Ensure compliance with regulatory requirements and company policies; support internal and external audits as needed.
• Set standards and implement continuous improvement initiatives to enhance quality, productivity, and cost efficiency.
• Collaborate with cross-functional teams and customers to ensure customer-centric design and satisfaction.
• Oversee performance management activities, including talent reviews, development plans, and engagement programs.
• Manage project budgets and contribute to business unit-level financial planning and forecasting.
• Provide strategic leadership for design controls and review technical documentation to ensure regulatory compliance.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• 8+ years of professional experience, including product development experience within a regulated industry.
• 2+ years of direct people management experience.
• Experience with design controls, NPD processes, and regulatory standards for medical devices.
• Project management experience delivering programs on time, on quality, and within budget.
• Professional certifications such as ASQ Certified Quality Engineer (CQE) or ISO Lead Auditor.
• Experience supporting New Product Development (NPD) activities within a Quality function.