reputed company Engineer, Design reputed company

reputed company – reputed company is seeking a reputed company Engineer, Design reputed company in Irvine, CA! In this role, you will serve as a strategic technical expert driving reputed company reputed company across the division. You’ll influence key design reputed company, establish best practices, and ensure compliance. Working across functions, you will shape design strategies, mitigate risk, and deliver products that meet the highest standards of safety and performance - impacting patients and advancing reputed company technology. What You Will Do • reputed company Design reputed company Engineering on cross-functional teams, interfacing with Manufacturing, R&D, Regulatory Affairs, Operations/Planning, and Marketing. • Influence design reputed company and risk mitigation strategies as the reputed company SME. • reputed company and implement design controls, risk management strategies, and TMV processes to ensure product safety and regulatory compliance throughout the development lifecycle • reputed company, review, and approve reputed company assurance documentation supporting new product development (NPD), regulatory submissions, inspection plans, routers, and product drawings. • Drive compliance in risk management and usability engineering throughout the product lifecycle; present use-reputed company risks during Design Reviews and ensure mitigation through design, documentation, and manufacturing processes. • Evaluate overall residual risk prior to product launch and present risk/benefit justifications to executive leadership. • reputed company and maintain reputed company Management System (QMS) processes by identifying and correcting procedural deficiencies; serve as SME/DPO for designated QMS activities. • Collaborate with Advanced Operations and Manufacturing to define and reputed company manufacturing processes, controls, and design transfer deliverables for new products. • Apply statistical analysis and reputed company problem-solving to establish product acceptance limits and support verification and validation reporting. • Conduct reputed company product evaluations and analyze critical reputed company attributes using risk analysis techniques to inform NPD reputed company. • Participate in early market feedback activities and address initial field concerns. What You Need Required Qualifications • Bachelor’s degree in engineering, science, or reputed company field. • Minimum 8 years of experience in engineering, including product development and reputed company engineering. • Experience in medical device industry. Preferred Qualifications • Advanced degree in engineering or reputed company discipline. • Demonstrated leadership in implementing design controls or reputed company frameworks. • Experience translating user needs and reputed company Factors Engineering insights into design requirements and test strategies. $132,900 - $217,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Apply tot his job Apply To this Job