Production Engineer - Medical Device Manufacturing

Candidates from Ambernath, Badlapur, Kalyan, Dombivli, Thane, Navi Mumbai, or nearby areas will be preferred.

Preferred: Candidates with hands-on experience in production, assembly, manpower supervision, and documentation in a factory or regulated manufacturing setup.

Educational Qualification

Mandatory Preferred Qualification:

BE B.Tech M.Tech in any of the following:

• Mechanical Engineering
• Production Engineering
• Industrial Engineering
• Manufacturing Engineering

Candidates with relevant experience in medical device manufacturing, assembly operations, injection moulding, QA/QC, or regulated production environments will be preferred.

Role Summary

We are looking for a competent and responsible Production Engineer to manage daily production and assembly activities for medical devices. The candidate will be responsible for production planning, shop-floor supervision, process monitoring, manpower handling, documentation, coordination with QA/QC, stores and maintenance teams, and ensuring that production is carried out as per defined quality and regulatory requirements.

The role requires a hands-on engineer who is comfortable working in a factory environment, supervising operators, maintaining production records, improving process efficiency, and ensuring timely completion of production targets without compromising quality.

Key Responsibilities

• Production Planning and Execution
• Plan, schedule, and monitor daily production and assembly activities.
• Ensure production targets are achieved as per the approved production plan.
• Allocate manpower, machines, tools, materials, and workstations effectively.
• Coordinate with stores, QA/QC, maintenance, purchase, and dispatch teams for smooth production flow.
• Monitor production output, rejection levels, downtime, and operator efficiency.
• Ensure proper line discipline, housekeeping, and adherence to work instructions.
• Assembly and Manufacturing Operations
• Supervise assembly of medical devices and related components.
• Ensure that operators follow approved SOPs, process sheets, drawings, and work instructions.
• Monitor critical process parameters during assembly and production.
• Support process improvements to reduce rejection, rework, downtime, and wastage.
• Identify production bottlenecks and suggest practical corrective actions.
• Ensure safe handling of components, raw materials, semi-finished goods, and finished products.
• Quality and Compliance
• Ensure that production activities are performed in compliance with company quality systems.
• Conduct or support in-process checks during production and assembly.
• Coordinate with QA/QC for inspection, release, non-conformance handling, and corrective actions.
• Support compliance with ISO 13485, GMP, and applicable medical device quality requirements.
• Report deviations, non-conformities, process issues, and quality concerns promptly.
• Participate in CAPA, root cause analysis, and process improvement activities.
• Documentation and Reporting
• Maintain accurate production records, batch records, daily production reports, and process logs.
• Ensure proper traceability of materials, components, batches, and finished products.
• Prepare and submit daily weekly production reports to management.
• Maintain documentation related to manpower deployment, rejection, rework, downtime, and corrective actions.
• Support internal and external audits by providing production records and explanations when required.
• Manpower Supervision
• Supervise production operators, helpers, technicians, and assembly staff.
• Train operators on SOPs, work instructions, safety practices, and quality requirements.
• Monitor attendance, discipline, productivity, and work allocation of shop-floor manpower.
• Motivate the team to achieve production targets while maintaining quality standards.
• Ensure proper communication between production workers and management.
• Process Improvement and Coordination
• Identify opportunities for improving productivity, quality, workflow, and material utilization.
• Work with QA/QC and maintenance teams to reduce downtime and improve process reliability.
• Support validation, trial production, new product introduction, and process change activiti