Advanced Quality Engineer

Work Flexibility: Hybrid or Onsite

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.

Workplace Flexibility: 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.

• 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.

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

• 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.