Job Description
Job Description
+ About the job:
The Production Manager will oversee daily manufacturing operations to ensure compliance with FDA regulations, ISO standards, and quality requirements. This role manages production teams, optimizes workflows, and drives continuous improvement in a highly regulated environment.
+ We’re looking for someone who:
- Holds a bachelor’s degree in Engineering (Mechanical preferred); master’s degree a plus
- Has 8–10+ years of production/manufacturing management experience in the medical device industry
- Is knowledgeable in FDA 21 CFR Part 820, ISO standards, GMP, and cleanroom operations
- Brings expertise in process validation, technical documentation, and regulatory compliance
- Applies Lean manufacturing, Six Sigma, and SPC methodologies to improve processes
- Has hands-on experience with tooling, fixtures, CAD design, and troubleshooting
- Is proficient in Microsoft Office and ERP/MRP systems (3D CAD experience a plus)
- Demonstrates strong leadership, team development, and communication skills
- (Preferred) Holds certifications in Lean, Six Sigma, or Project Management
- (Preferred) Has experience in high-volume cleanroom manufacturing
+ What you’ll do:
- Lead and develop production teams to achieve safety, quality, and efficiency goals
- Manage production schedules and coordinate with planning, engineering, and quality teams
- Monitor production metrics and implement corrective/preventive actions
- Oversee cleanroom operations and environmental monitoring
- Ensure compliance with FDA, ISO, GMP, and company SOPs
- Support audits, CAPAs, MRB activities, and documentation requirements
- Design and optimize process flows, work instructions, and manufacturing lines
- Lead validation activities for new processes, equipment, and packaging
- Develop and troubleshoot production tooling and fixtures
- Partner with suppliers and QA teams on audits, qualifications, and SCAR resolutions
- Collaborate with customers on new product introductions and technical requirements