Operations Manager

Responsibilities

• Lead a manufacturing and warehouse organization of 130+ employees managing extruded thermoplastic medical device components and finished device assembly.
• Monitor daily production to achieve output, schedule attainment, quality, and productivity targets.
• Ensure all operations adhere to Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and internal QMS requirements.
• Manage production capacity, annual headcount budgets, and operational expense budgets.
• Collaborate with Supply Chain to finalize weekly production schedules and investigate production control problems.
• Implement continuous improvement initiatives to improve efficiency and reduce manufacturing costs.
• Oversee finished goods inventory levels and manage the site's MRO supplies kanban system.
• Partner with New Product Development to ensure design-for-manufacturing considerations are incorporated for smooth commercial launches.
• Develop succession plans and training programs to promote staff career development and operational flexibility.

Requirements

• Bachelor's Degree (Engineering or Operations Management preferred).
• 5+ years of manufacturing or operations management experience in a medical device or pharmaceutical production facility.
• Experience leading large 24/7 production organizations.
• Strong familiarity with ISO13485 and FDA 21 CFR Part 820 GMP requirements.
• Proficiency with ERP systems and computer software.
• Proven experience formulating and driving KPIs to meet corporate goals.

Preferred Qualifications

• Experience with thermoplastic extrusion operations and medical device assembly.
• Knowledge of lean manufacturing and fundamental Six Sigma statistical concepts.
• Ability to work in ISO class 7 and class 8 cleanroom environments.
• Familiarity with standard cost models and capacity resource planning methodologies.

Benefits

• Competitive salary with a 15% performance-based bonus.
• 401(k) match and Age-Weighted Defined Contribution.
• Comprehensive medical, dental, and vision coverage.
• Health Savings Account (HSA).
• Paid holidays, vacation, and parental leave.
• Learning and development opportunities.

About the Company

Lubrizol Corporation, a Berkshire Hathaway company, is a global leader in specialty chemistry. For nearly 100 years, we have been at the forefront of innovation, providing solutions for the medical device, mobility, and performance coatings industries. We are dedicated to transforming industries through science, sustainability, and a culture of inclusion.