Job Description

Responsibilities:

• Lead the development, optimization, and implementation of manufacturing processes.
• Drive operational excellence, improving product quality, and ensuring efficient production workflows.
• Design and implement manufacturing processes that improve efficiency, reduce costs, and meet quality standards.
• Analyze existing workflows and identify opportunities for automation, standardization, and waste reduction.
• Collaborate with design and R&D teams to ensure manufacturability of new products.
• Develop test methods and author process validation protocols and reports.
• Collaborate with engineering to develop, document, and build prototypes, tooling, and fixtures to produce products according to design, quality specifications, and budget.
• Lead troubleshooting and root cause analysis for process and equipment failures.
• Plan and manage manufacturing projects, ensuring timely delivery and alignment with organizational goals.
• Track material lead times, scrap rates, and product delivery schedules.
• Support product transfer from R&D to pilot production and full production through training and process development.
• Interact with outside vendors including third-party sterilizers and contract testing labs in order to accomplish project deliverables.
• Implement cost reductions by working closely with production to reduce scrap and waste and improve efficiencies.

Qualifications

Requirements

• Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or a related field.
• 8+ years of experience in manufacturing, process and/or continuous improvement engineering.
• Must come from a highly regulated industry such as medical device, pharmaceutical, aerospace, military, etc.
• Strong knowledge of Lean manufacturing principles and Six Sigma methodologies (certification is a plus).
• Ability to manage multiple projects and work effectively in a team-oriented environment.
• Familiarity with statistical process control and metrology.
• Proficiency in CAD software, ERP systems, and manufacturing tools.

Additional Information

All your information will be kept confidential according to EEO guidelines.