
Production Operations Director
1 week ago
Job Summary:
">We are seeking a highly experienced Production Manager to oversee the planning, execution, and supervision of production processes within our medical device manufacturing environment. This role requires a strong background in production management, with experience in regulated industries and adherence to GMP, ISO 13485, 21 CFR Part 820, and EU MDR guidelines.
">Key Responsibilities:
">Plan and execute production schedules to meet delivery timelines and targets
Supervise all processes of medical devices manufacturing
Ensure uninterrupted production by managing material flow, manpower, and equipment availability
Maintain complete and compliant Device History Records (DHR) and Batch Manufacturing Records (BMR)
Support internal, external, and regulatory audits, including FDA and notified body inspections
Lead, train, and mentor production teams, including Assistant Managers, Technicians, and operators
Conduct performance evaluations and ensure skill development plans are implemented
Promote a culture of accountability, safety, and continuous improvement
Collaborate with Engineering and R&D to support design transfer and process validation
Reduce production waste, rework, and downtime through data-driven improvements
Ensure the proper operation, calibration, and maintenance of production equipment and cleanroom infrastructure
Monitor environmental parameters to maintain ISO Class 7 cleanroom compliance
Coordinate with maintenance and EHS teams for facility upkeep and safety compliance
Investigate production issues, deviations, and non-conformances
Implement corrective and preventive actions in collaboration with QA/QC
Lead cross-functional root cause analysis and problem-solving initiatives
Monitor and report key production metrics, including output, yield, rejection rate, efficiency, and downtime
Present monthly performance summaries and improvement plans to leadership
Requirements and Qualifications:
">To be successful in this role, you will need a Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering, or a related field, as well as at least 5-10 years of experience in production management within a regulated medical device manufacturing environment.
">You should have strong knowledge of GMP, ISO 13485, 21 CFR Part 820, and EU MDR, as well as familiarity with cleanroom operations, device assembly, and sterile packaging. Additionally, you should possess demonstrated leadership in team management, lean manufacturing, and production scale-up.
">About Us:
">We are committed to delivering high-quality medical devices that meet the needs of patients and healthcare professionals. Our team is passionate about innovation, quality, and customer satisfaction.
">How to Apply:
">Please submit your resume and cover letter for consideration.
">Seniority level: Mid-Senior level">Employment type: Full-time">Job function: Marketing, Public Relations, and Writing/Editing">Industries: Medical Equipment Manufacturing-
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