Engineer II - Design Quality - Sustainability at Arthrex, Inc. in Naples, Florida

Job Description:

Requisition ID: 55261 Title: Engineer II - Design Quality - Sustainability Division: Arthrex, Inc. (US01) Location: Naples, FL

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II - Design Quality, Sustainability who will contribute to post-launch design-related activities while interfacing with engineering teams and manufacturing facilities. The successful candidate will have a Bachelors' degree in Engineering and two years relevant experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Support Design Quality Engineering efforts on product sustainability of released products to the market.


• Review production specifications, when requested by manufacturing, to clarify requirements, establish practical inspection methodologies, and/or improve product requirements for the overall manufacturability of products with the support of Design Engineering and manufacturing facilities.


• Ensure Essential Design Outputs remain under appropriate manufacturing process control throughout the product lifecycle.


• Perform root cause investigation as part of improving product quality/performance issues as a result of design failure modes stemming from product design and/or manufacturing process.


• Maintains understanding and regulations/standards from product release through product retirement, acting as a resource to other functional groups, within the product design change process


• Support product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.


• Display working knowledge in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance.


• Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.


• Provide direction on how to perform Test Method Validations, where appropriate, leads efforts to reduce test method bias ensuring a robust accept/reject process. It could require training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.


• Provide statistical techniques for appropriate product testing strategies in alignment to risk levels estimated from the Risk Management process.


• Support NCRs and CAPAs related to design and/or inspection/test methods.

Education and Experience:

• Bachelor's degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.


• 2 years design assurance / quality assurance experience in a medical device or other highly regulated industry required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Working knowledge of ISO and FDA design and development quality requirements.

• Technical and working knowledge in Six Sigma and Lean methodologies.


• Proficiency in assessing manufacturing quality requirements.


• Technical knowledge in development methodologies, and project implementation, including but not limited to, GD&T & DOE preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.