POSITION SUMMARY: The Design Quality Engineer will develop and implement compliance strategies to support new product introductions & development within the areas of design, design transfer, manufacturing, and service. The Design Quality Engineer will ensure adherence to Quality Management Systems and regulatory requirements, use critical thinking and influencing skills to work cross-functionally to ensure robust quality decisions, and create a Quality culture by driving compliance activities.

ESSENTIAL FUNCTIONS:

• Work with high-performing cross-functional teams to sustain the quality of medical device products
• Responsible for Quality functions that impact patient care by ensuring the safety, quality, audit readiness, post-market performance, and compliance of products
• Interface with cross-functional teams to complete sustaining projects, design control deliverables, and activities to ensure that medical device products continue to meet state-of-the-art regulatory standards and user needs
• Effectively work with and influence cross-functional teams during the Design Change process to ensure proposed changes to products are systemically and thoroughly analyzed, assessed, controlled, and implemented appropriately (i.e., EN 13485 / CFR820)
• Support Risk Management planning, updating, and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with company and various industry standards
• Support Usability Engineering and planning documentation
• Support the sustaining effort for both product and packaging designs
• Support manufacturing operation efforts and changes to ensure they meet or exceed internal and external requirements
• Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem-solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues
• Support post-market activities ensuring products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals