MEDICAL DEVICE Design Quality Engineer Senior 2- Sustainability
Seeking a Design Quality Engineer Senior 2- Sustainability works directly with the Design Engineering teams. In this role you are responsible for driving post-launch design related activities while interfacing with engineering teams and manufacturing facilities This position requires leadership skills to lead quality improvement projects and other Design Quality Engineers. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering or Engineering Technology will be essential for this position.
Essential Duties and Responsibilities:
- Lead 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 Ouputs 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 steming from product design and/or manufacturing process.
- Provide active leadership in understanding and implementing regulations/standards from product release through product retirement, acting as a resource to other functional groups, within the product design change process
- Use metrics related to sustainability activities to influence and/or drive improvements to design processes (e.g. Design Outputs, Design Transfer, etc..) and any other relevant quality management system.
- Lead 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 and provide guidance to design change teams in the area of usability/human factors engineering priniciples 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.
- Ensure that proper training and/or process changes are implanted to ensure that Design Changes are properly and consistently documented, and reviewed by approvers quality in ordet to be compliant to all applicable standards, regulations, and internal QMS requirements across the organization.
- Provide statistical techniques for appropriate product testing strategies in aligment 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 or Engineering Technology required; Biomedical, Mechanical, or Electrical Engineering degree preferred.
- 8 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 Sigman 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.
UP TO 125K BASE