Principal Engineer, Design Quality

Stryker•Irvine, CA

11d•Onsite

About The Position

Stryker – Inari Medical is seeking a Principal Engineer, Design Quality in Irvine, CA! In this role, you will serve as a strategic technical expert driving quality excellence across the division. You’ll influence key design decisions, 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 healthcare technology.

Requirements

Bachelor’s degree in engineering, science, or related field.
Minimum 8 years of experience in engineering, including product development and quality engineering.
Experience in medical device industry.

Nice To Haves

Advanced degree in engineering or related discipline.
Demonstrated leadership in implementing design controls or quality frameworks.
Experience translating user needs and Human Factors Engineering insights into design requirements and test strategies.

Responsibilities

Lead Design Quality Engineering on cross-functional teams, interfacing with Manufacturing, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
Influence design decisions and risk mitigation strategies as the quality SME.
Develop and implement design controls, risk management strategies, and TMV processes to ensure product safety and regulatory compliance throughout the development lifecycle
Develop, review, and approve quality 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-related 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.
Lead and maintain Quality 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 develop manufacturing processes, controls, and design transfer deliverables for new products.
Apply statistical analysis and structured problem-solving to establish product acceptance limits and support verification and validation reporting.
Conduct predicate product evaluations and analyze critical quality attributes using risk analysis techniques to inform NPD decisions.
Participate in early market feedback activities and address initial field concerns.