Engineer II QA Design - Sustaining

Requisition Details

Requisition : 64678

Title: Engineer II QA Design - Sustaining

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 for our global headquarters in Naples, FL. The Engineer II contributes to post-launch design‑related activities while interfacing with engineering teams and manufacturing facilities. This position requires time management skills to assist with project completions and supporting other Design Quality Engineers.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• 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.
• Maintain 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., ISO
  14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.
• Lead the enhancement and continuous improvement of the Risk Management processes for medical devices, including the creation, oversight, and global harmonization of policies and procedures.
• 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, lead 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.

• 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.

• 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.

• Proficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software.
• Hands on experience with SAP and Agile preferred.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.