Advanced Quality Engineer

Engineer, Advanced Quality Engineering

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.

What you will do:

• 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.

What you will need:

Required:

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

Preferred:

• + 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.

$76,500 – $122,000 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.