Participate in large scale projects or lead smaller scale projects under guidance from senior engineering staff. Competent in the use of all relevant business tools including product qualification activities, change management, process development, cost reduction, capacity management, NCEP process, and all required PDM activity.
Participate in project teams cooperating with cross functional team members (R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, Marketing, etc.) to qualify and improve supplier processes.
Understand Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
Interface with suppliers with support from commodity team members to support 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.
Support NCEP/CAPA investigations to determine and address root cause for defective components at receiving inspection. Support product complaint investigations.
Ability to troubleshoot new and existing product/process problems related to design, material, or processes including summarizing, analyzing, and drawing conclusions from test results.
Prepare standard reports/documents to communicate results to the technical community.
Submit and manage Change Requests to support manufacturing changes
Ensure that adequate Corrective Actions are identified, implemented and controlled by Suppliers
Education & Experience
Between 3+ years’ experience in a Supplier Engineering or Engineering Project Management Role
Level 8 qualification in a relevant Engineering or Science discipline.
Experience working with suppliers and/or contract manufacturers
Proven ability to solve technical problems and implement solutions
Strong verbal and written communication skills.
Ability to travel up to 25% (domestic and international). Travel typically does not occur over weekends.
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 and six sigma methodologies
Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics.