Responsibilities:
- Partnering with senior engineers to lead and support projects for product qualification, change management, process development, cost reduction, capacity management, and all related PDM activity
- Supporting product complaints and NCEP/CAPA investigations of defective components received to identify and address root causes
- Collaborating with cross-functional teams to qualify and improve supplier processes; submit and manage manufacturing change requests as necessary
- Collaborates with suppliers and extended team for investigation of device issues or supply constraints through use of process capability studies, Six Sigma and Value Improvement projects, report preparation and process/test documentation.
- Troubleshooting new and existing product issues related to design, material, or processes; analyze and interpret test results and use standard reports and documentation communicate findings to key stakeholders
- Ensuring corrective actions are identified, implemented and controlled by suppliers
Education & Experience:
- Bachelor's degree in any engineering discipline with a minimum of 3 years engineering experience
- Experience working with suppliers and/or contract manufacturers
- Experience managing technical problems and solution implementation
- Ability to travel up to 25% (domestic and international)
- Experience working in medical device or similarly regulated industry
- Ability to communicate effectively on all levels with strong technical writing and reporting skills
- Organized and detail-oriented; ability to prioritize and manage multiple projects
- Strong interpersonal skills with ability to develop internal and external relationships
- Results-driven with strong critical thinking and analytical skills
- Good understanding of, statistical methods, problem-solving techniques, lean manufacturing and six sigma methodologies
- Understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
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