Advanced Quality Engineer

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:

• Bachelors 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.

$76500 - $122000 USD Annual