Lead design and process changes for commercial products to improve performance, reliability, compliance, and cost. Evaluate and implement material changes, supplier updates, and manufacturing transfers to maintain supply continuity. Analyze product and process issues, determine root causes, and implement corrective actions. Develop and execute prototyping and testing to validate design changes to existing products. Author, review, and maintain engineering documentation, including design history files and technical reports. Apply applicable regulations and standards to design controls, risk management, and product validation activities. Partner with suppliers to establish and sustain manufacturing processes and product capabilities. Collaborate with cross-functional teams to implement product changes into production and mitigate associated risks. Partner with product transfer teams to support supplier transitions and ensure smooth handoffs into production. What you will need. Required qualifications. Bachelor’s degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or related field. Minimum 4 years of engineering experience in product or sustaining engineering, product development, or manufacturing in a regulated environment. Preferred qualifications. Experience applying design controls, risk management, and quality system requirements. Experience with electromechanical or mechanical product design. Strong experience with manufacturing process and production environments. Experience applying structured root cause analysis methodologies (e.g., 5 Whys, Fishbone) to investigate and resolve product or process issues. Experience using CAD tools (e.g., Solid. Works) to create engineering drawings with GD&T principles. Experience with injection molding or precision metal components US 10: $98,200 - $163,700 USD Annual. View the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 20%