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
Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).