Advanced Quality Engineer

Stryker•Tempe, AZ

4d•Hybrid

About The Position

Stryker is hiring an Engineer, Advanced Quality Engineering for our Sustainability Solutions team supporting our reprocessing product line. You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer. Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.

Requirements

Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, Biomedical Engineering or related Science or engineering discipline

Nice To Haves

Experience in data collection, data analysis, and scientific method.
Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.
Previous medical device industry experience preferred
Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.

Responsibilities

Represents Quality Assurance on New Product Development (NPD) cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
Supports Risk Management activities, including creating and implementing Risk Management Files, identifying hazards, and ensuring compliance with corporate and local design control procedures.
Plans, designs, and implements inspection, testing, and evaluation methods to ensure product and production reliability, applying advanced statistical techniques for test sample size determinations.
Supports Design Reviews to ensure design and process robustness, compliance with applicable regulations (e.g., QSR, ISO 13485), and proper risk analysis for new medical devices.
Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
May interact with customers to address product quality concerns, provide training on quality assurance and GMP topics, and support continuous improvement initiatives.