Quality Engineer

Responsibilities

• Promote an inclusive and healthy environment in alignment with the Gore CulturePlan and execute design assurance / product quality engineering work in collaboration with technical leadership and cross-functional partners to support new product development
• Apply design control processes throughout product development to ensure products meet user needs, intended use, and performance expectations
• Develop and refine user needs, design inputs, and design outputs, ensuring product requirements are clear, measurable, testable and traceable to support effective verification, validation, and evaluation of product performance
• Develop, improve, and validate test methods used to evaluate product or process performance, including supporting creation of new methods as required for product development
• Plan, support, and execute design verification and design validation activities to ensure product safety, effectiveness, and performance across intended use conditions
• Identify, evaluate, and mitigate product risks throughout development, including application of design and usability risk management approaches (e.g., dFMEA, uFMEA)
• Lead technical investigations and problem-solving efforts to address product or process issues, resolve technical uncertainties, and improve product performance
• Ensure design control documentation and traceability meet Design History File (DHF) expectations, including linkage across user needs, design inputs, design outputs, risk controls, and verification/validation activities
• Document and communicate technical plans, experimental results, and conclusions in alignment with quality system and regulatory requirements

Requirements

• For an Experienced engineering position, a Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals and a minimum of 3 years of applied experience OR a Master’s degree with a minimum of 2 years in applied experience
• For a Senior engineering position, a Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals and a minimum of 5 years of applied experience OR a Master’s degree with a minimum of 4 years in applied experience
• Demonstrated experience identifying, evaluating, and mitigating product or process risks using structured risk management approaches
• Demonstrated experience working within a regulated quality system (QMS), with exposure to areas such as design controls, investigations, or corrective and preventive action processes
• Demonstrated experience developing, executing, or improving test methods used to evaluate product or process performance
• Demonstrated ability to interpret, evaluate, and apply technical requirements, specifications, and acceptance criteria to support engineering decisions and evaluation of product performance (Demonstrated experience with bidirectional traceability – maintaining links from user need, system, subsystem and test, with full audit history)
• Demonstrated ability to analyze technical data and apply statistical methods to characterize product or process performance and support engineering decisions
• Demonstrated understanding of sampling plans and data-based decision making in a regulated environment
• Demonstrated ability to solve technical problems and make informed engineering decisions
• Demonstrated ability to work independently and collaborate effectively across functions to resolve technical challenges and drive work to completion
• Strong written and verbal communication skills, including ability to clearly document technical rationale, results, and conclusions

Qualifications

• For an Experienced engineering position, a Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals and a minimum of 5 years of applied experience OR a Master’s degree with a minimum of 4 years in applied experience
• For a Senior engineering position, a Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals and minimum 7 years of applied experience OR a Master’s degree with a minimum of 6 years in applied experience
• Familiarity with medical device quality system and regulatory expectations, including FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, and design control requirements
• Relevant engineering experience in the medical device industry, including familiarity with applicable regulatory standards and quality system expectations
• Experience with design controls, risk management, and requirements management within new product development (NPD) environments