Principal Engineer, Design Quality

Work Flexibility : Onsite

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. Youll 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.

What You Will Do

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.

What You Need

Required Qualifications

Bachelors 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.

Preferred Qualifications

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.

$132900 - $217500 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage : None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M / F / Veteran / Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.

Required Experience :

Staff IC

Key Skills

Design,Academics,AutoCAD 3D,Cafe,Fabrication,Java

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 132900 - 217500