Stryker Belfast, Northern Ireland, United Kingdom
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Stryker Belfast, Northern Ireland, United Kingdom
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Position Summary
Senior Design Quality Engineer (Hybrid)
Stryker is hiring a Senior Design Quality Engineer in Redmond, WA, to support our Medical Business. You will work as the Design Quality Engineering partner within a cross-functional product development team to enable the timely launch of high-quality products that meet and exceed customer and stakeholder expectations, supporting the product lifecycle of a medical device. You will serve as a representative for the Quality Management System and drive continuous process improvement.
What you will do:
* Participate in the product development process by ensuring that all quality data streams are fully understood and that customer feedback (complaints, non-conforming records, verified failures, etc.) informs design inputs and considerations.
* Lead product safety Risk Management activities, including characterization and estimation of design risks, control activities, and proper identification in downstream design outputs. Develop Risk Management File deliverables such as Product Hazard Analysis, DFMEA, Critical to Quality characteristics, and Risk Assessments.
* Develop validation strategies aligned with design validation policies and procedures. Provide technical direction and approval of validation plans, protocols, and reports.
* Provide technical guidance to optimize test plans, test methods, and sampling procedures.
* Lead initiatives and projects to improve Quality organization-wide.
* Establish field performance trending metrics, analyze results for emerging trends and improvement opportunities, and report on production and post-market monitoring.
* Provide Quality leadership to resolve issues impacting product lines and participate in CAPA processes. Advise on risk management investigations for HHE, PFAs, NCs, and CAPAs.
* Participate in internal and external audits, providing expertise and overview of product development within the Design Controls process.
* Seek learning opportunities across Stryker to advance technical skills and develop subject matter expertise.
What you will need:
* Bachelor's Degree in Engineering (Biomedical Engineering preferred)
* 2+ years of experience in a regulated environment, quality, manufacturing, or engineering
* Strong knowledge of medical device policies and regulations
* Experience with electro-mechanical commodities and embedded software in product development
* Knowledge of quality tools such as process capability, root cause analysis, sampling plans, and validation
* Understanding of good design practices, specifications, and industry standards
Stryker is a global leader in medical technologies, striving to improve healthcare outcomes through innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine. The company impacts over 150 million patients annually.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Appliances, Electrical, and Electronics Manufacturing
* Industrial Machinery Manufacturing
* Medical Equipment Manufacturing
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