Senior Staff Engineer, Design Quality

Stryker•Irvine, CA

2d•$100,700 - $165,100•Onsite

About The Position

Stryker - Inari Medical is hiring a Sr. Staff Engineer, Design Quality in Irvine , California ! In this role, you will partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes that support new product development projects. You will also lead risk management activities to ensure the highest level of product and process quality!

Requirements

Bachelor’s degree in science, engineering or related discipline.
6+ years’ related experience required.
Medical device industry experience required.
Familiarity with New Product Development (NPD) processes and/or involvement in cross-functional activities supporting product development and commercialization.

Nice To Haves

MS, CQE, or CRE preferred.
Six Sigma Green or Black belts are preferred.
Experience with the medical device development lifecycle, including risk management and design/process verification and validation.
Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts.
Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations.
Proven project management and cross-functional collaboration skills.
Excellent communication, problem-solving, and analytical abilities.

Responsibilities

Develop quality documentation to support new product development and regulatory submissions.
Maintain and improve quality systems by identifying and correcting procedural deficiencies.
Lead risk management activities and present final risk/benefit justifications to leadership.
Help create, maintain, and manage risk files throughout the product lifecycle.
Drive product and process design activities in cross-functional teams.
Define and validate design verification and validation (V&V) test requirements and methods.
Present product risks during design reviews and ensure mitigation through development.
Support manufacturing process development and product design transfer to internal/external sites.
Apply statistical analysis and problem-solving techniques to define acceptance criteria and resolve quality issues.
Review and approve inspection plans, routers, and product drawings.
Evaluate predicate devices and define critical quality attributes through risk analysis.
Contribute to final V&V reports with statistically valid conclusions and graphical summaries.
Support early market feedback collection and resolution of initial product concerns.