Job Description
Pay Range: $48hr - $52hr
Responsibilities
* Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design to ensure parts, equipment, tools, fixtures, etc. are up to standards
* Use technical principles, problem solving skills, and data analysis to support and problem-solve for production at contract manufacturer.
* Work and lead initiatives to support manufacturing projects and goals (material qualification, supplier/label/part/product changes, product enhancements, equipment qualifications, tolerance stack analysis through technical advancements, problem solving skills, and process excellence methodologies.
* Support key project initiatives (supplier transfers, part changes, system enhancements, line extensions, cost reductions, labor efficiency improvements, and quality and compliance excellence).
* Manage change control for ongoing manufacturing changes, including CAD updates, change requests, process changes, Device Master Record, product specifications, test processes, and product service processes.
* Review all incoming PCNs and assess any changes (material, mechanical, electrical, datasheet, etc.)
* Route PCNs with relevant changes to designated product owners.
* Maintain a tracking system for PCNs reviewed, routed, and approved. Collaborate with the team to refine triage criteria and improve efficiency.
* Deploy, review, and act upon meaningful metrics to measure, control, define, refine, and optimize processes and for process control and continuous improvement.
* Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
* Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
* Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
* Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
* Other incidental duties assigned by Leadership.
Education and Experience
* Bachelor's Degree in Engineering or Scientific field with, 5 years’ experience including either industry or industry/education Required or Master's Degree or equivalent in Engineering or Scientific field with, 4 years’ experience including either industry or industry/education Required or
* Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required.
Additional Skills
* Proven expertise in usage of MS Office Suite including MS Project.
* Proven expertise/knowledge using Windchill PLM. Teamcenter also preferred.
* Ability to use Mechanical CAD tools (SolidWorks, CREO, ProE).
* Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
* Basic understanding of statistical techniques.
* Previous experience working with lab/industrial equipment (if applicable).
* Substantial understanding and knowledge of principles, theories, and concepts. relevant to Engineering and best practices.
* Strong problem-solving, organizational, analytical and critical thinking skills.
* Substantial understanding of processes and equipment used in assigned work.
* Good leadership skills and ability to influence change.
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