Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is hiring a SENIOR CUSTOMER QUALITY ENGINEER (Hybrid) located in REDMOND, WA!

Hybrid Definition: Candidate must reside within a commutable distance to Redmond, WA but is expected to be onsite at the facility multiple times/week.

Who we want

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As a Senior Customer Quality Engineer, you will be responsible for continuous product and process quality improvements. You will conduct investigations into NCs and CAPAs stemming from the products in the field. You will support root cause activities and identify potential failure modes and risks and resolves customer issues appropriately

• Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to identify opportunities for quality improvements
• Ownership of activities that lead to improvement in Physio-Control Quality metric (Q)
• Support NC and CAPA process and NC and CAPA investigations
• Communicate with Customers, members of Field Service and Sales organizations to gather information necessary to carry out investigations and document accurately and thoroughly NC and CAPA investigations
• Work with cross-functional teams (Ex: R&D, Operations, Manufacturing Engineering, Field Service, and Sales) to drive resolution for NCs and CAPAs
• May support Engineering Change Orders (ECO) and Process Change Orders (PCO)
• Support and communicate with complaint handling function to ensure trending information is accurate and up to date
• Champion determination of “true” root cause by utilizing appropriate problem-solving tools
• Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.
• Calculate Failure/Harm occurrence rankings based on field data as required
• Provide post-market input and feedback on safety, durability, craftsmanship, and reliability design input specifications for Quality report, design reviews, risk analyses, and customer research.
• Develop statistical rationale for testing, when required, to address post market issues.
• Develop the rationale for validation sample size, duration, and number of locations.
• Provide Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to the organization Present Post Market trending data to the business
• Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary.
• Support field action related activities i.e. investigations, HHEs, presentations etc.
• Support internal and external audits (FDA, ISO, MDSAP etc.

What you need

Required

• Bachelor’s Degree in Engineering or a Science
• 2+ years’ experience in engineering

Preferred

• Bachelor’s degree in Electrical, Mechanical, or quality engineering discipline
• Experience in a regulated industry (Medical, Aerospace, etc.) is a plus

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com