Engineering Manager, Design Quality
Engineering Manager, Design Quality
Portage, MI
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.
Preferred Qualifications
- 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
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