Responsibilities will include:
• 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.
•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, and audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes
• Lead and establish project plans to ensure deliverables are completed to customer expectations using project management tools (e.g., project plans and risk analyses)
• Perform other incidental duties as assigned by leadership
Education and Experience:
Bachelor’s degree in engineering or a related scientific field with at least 5 years of relevant industry or combined industry and academic experience; or
Master’s degree in engineering or a related scientific field with at least 4 years of relevant industry or combined industry and academic experience; or
Ph.D. in Engineering or a related scientific field with relevant industry or academic experience.
Required Skills:
• Proficiency with Microsoft Office applications, including Microsoft Project
• Ability to read electronic schematics and mechanical drawings
• Experience with Windchill PLM
• Experience with mechanical CAD tools such as SolidWorks, Creo, or Pro/ENGINEER
• Strong technical writing, documentation, presentation, and verbal communication skills
• Demonstrated analytical, problem-solving, critical-thinking, and organizational skills
• Demonstrated strong accountability and ownership, with a proven ability to take responsibility for commitments, proactively drive work to completion, and follow through on deliverables
• Working knowledge of statistical methods, engineering principles, manufacturing processes, process controls, and production equipment
• Ability to manage multiple priorities and work effectively with cross-functional teams in a fast-paced environment
• Demonstrated ability to lead initiatives, influence change, and collaborate with internal teams, suppliers, and senior stakeholders
• Strong attention to detail and commitment to quality, compliance, and workplace safety
Preferred Skills:
• Experience with Teamcenter PLM
• Familiarity with medical device quality systems and regulations, including ISO 13485 and 21 CFR Part 820
• Lean Champion or Six Sigma certification
• Experience troubleshooting finished devices, subassemblies, and component failures and documenting evaluation results
• Experience with clean-room manufacturing, laboratory, or industrial equipment
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