Principal Manufacturing Engineer, External Products
About The Position
Manage projects which include new production equipment, process improvements, and cost reductions while supporting day to day operations success of assigned key SFMD suppliers. Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success. Successfully contributes to both new product development and current product support, typically including the following activities: process capability studies, process development, Six Sigma and Value Improvement projects, report preparation and process/test documentation. Ability to independently design and coordinate engineering tests and experiments including Design of Experiments. Ability to independently troubleshoot new and existing product/process problems related to design, material, or processes. Summarizes, analyzes, and draws conclusions from test results. Prepares standard reports/documents to communicate results to the technical community. May lead cross-functional project teams. Trains and/or provides work direction to operators/technicians at BSC Supplier Site. Submit and manage Change Requests to support manufacturing changes Independently executes plans to support supply chain objectives; supplier performance, supplied material risk mitigation and execution of materials VIP. Can communicate plans at a high level within the organization and organize projects by requesting support at plant management level. Proficient in the use of all business tools. Leads project teams coordinating the efforts of engineers and cross functional team members to qualify and improve supplier processes. Plans, schedules, conducts or coordinates all phases of the engineering work for of a major project. Performs work that involves conventional engineering practice but may include a variety of complex features such a conflicting design requirements, unsuitability of standard materials, and difficult coordination requirement. Expert in the use of statistical tools (re. Six Sigma Black Belt). Can provide guidance to junior engineering staff on problem solving methodology. Broad familiarity with analytical techniques commonly used to investigate component defects. Highly in report writing skills; ability to tailor technical message to suit audience. Subject matter expert for component qualification activities- First Article and Acceptance Activities. Proficiency in BSC systems and processes: PDM, NCEP, eCAPA
Requirements
- Bachelors Degree in Engineering from ABET accredited institution
- 10+ years' experience in Medical Device operations
- Desire for a career in people leadership
- Proven organization and execution skills
- Proven ability to solve technical problems and implement solutions
- Proven leader and team player with the ability to drive tasks / projects to completion
- Willing and able to work with engineers and technical staff from a SFMD Supplier at a different site
- Strong verbal and written communication skills
- Ability to travel up to 25% of the time
- Travel typically does not occur over weekends
- Expert in the use of statistical tools (re. Six Sigma Black Belt)
- Broad familiarity with analytical techniques commonly used to investigate component defects
- Highly in report writing skills; ability to tailor technical message to suit audience
- Subject matter expert for component qualification activities- First Article and Acceptance Activities
- Proficiency in BSC systems and processes: PDM, NCEP, eCAPA
Nice To Haves
- Masters Degree, or equivalent, in Engineering or Sciences from ABET accredited institution
- Previous direct supervisory experience
- Manufacturing experience
- Medical Device experience
- Can provide guidance to junior engineering staff on problem solving methodology
Responsibilities
- Manage projects which include new production equipment, process improvements, and cost reductions while supporting day to day operations success of assigned key SFMD suppliers.
- Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success.
- Successfully contributes to both new product development and current product support
- Process capability studies
- Process development
- Six Sigma and Value Improvement projects
- Report preparation and process/test documentation
- Independently design and coordinate engineering tests and experiments including Design of Experiments
- Independently troubleshoot new and existing product/process problems related to design, material, or processes
- Summarizes, analyzes, and draws conclusions from test results
- Prepares standard reports/documents to communicate results to the technical community
- May lead cross-functional project teams
- Trains and/or provides work direction to operators/technicians at BSC Supplier Site
- Submit and manage Change Requests to support manufacturing changes
- Independently executes plans to support supply chain objectives; supplier performance, supplied material risk mitigation and execution of materials VIP
- Can communicate plans at a high level within the organization and organize projects by requesting support at plant management level
- Leads project teams coordinating the efforts of engineers and cross functional team members to qualify and improve supplier processes
- Plans, schedules, conducts or coordinates all phases of the engineering work for of a major project
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
