Production Engineer - IVD | Instrumentation

Genes2me; Gurugram District; On-site; INR 8,00,000 - 12,00,000; Full time

Job summary

A leading medical device company is seeking an experienced Production Engineer in Gurugram to manage daily production activities for RT-PCR medical devices. The ideal candidate will have a B.Tech in a relevant field and 3-4 years of experience in IVD manufacturing. This role offers the opportunity to work in a collaborative environment focused on quality healthcare solutions.

Benefits

Opportunity to work with advanced technology

Collaborative work environment

Professional growth through continuous learning

Qualifications

• 3 to 4 years of production experience in IVD medical device manufacturing.
• Knowledge of ISO 13485 and GMP compliance requirements.

Responsibilities

• Manage daily production activities for IVD RT-PCR medical device manufacturing.
• Ensure adherence to ISO 13485 and GMP guidelines.
• Operate and maintain critical production equipment.
• Coordinate with planning and supply chain teams.
• Perform in-process checks for quality.

Skills

Problem-solving skills

Troubleshooting skills

MS Office proficiency

Education

B.Tech/ B.E in Biomedical, Instrumentation, Electronics, or Mechanical Engineering

Job description

About the Role

We are looking for an experienced Production Engineer to join our team in the In Vitro Diagnostics (IVD) sector. This role involves managing daily production activities for RT-PCR medical devices, ensuring compliance with ISO 13485 and GMP standards, and driving efficiency, quality, and continuous improvement within the production process.

Key Responsibilities

• Execute and monitor daily production activities for IVD RT-PCR medical device manufacturing.
• Ensure adherence to ISO 13485 and GMP guidelines throughout the production process.
• Operate and maintain critical production equipment.
• Coordinate with planning and supply chain teams to ensure timely availability of raw materials.
• Maintain inventory control of production materials and consumables.
• Maintain proper documentation including BMRs, batch records, line clearance reports, and deviation logs.
• Perform in-process checks to ensure consistency and quality of products.
• Monitor environmental conditions and ensure compliance with cleanroom protocols.
• Support validation activities (IQ, OQ, PQ) for equipment and processes.
• Identify and troubleshoot process-related issues and implement corrective actions.
• Participate in root cause analysis (RCA) and CAPA implementation for process deviations.
• Collaborate with QA/QC teams for batch release, product testing, and compliance.
• Support training of new team members and operators on SOPs and best practices.
• Monitor and record equipment calibration and preventive maintenance schedules.
• Review and revise SOPs, WI, and other controlled documents periodically.
• Contribute to continuous improvement initiatives to enhance productivity and efficiency.
• Coordinate with regulatory and audit teams during internal/external inspections.
• Report daily progress, issues, and production metrics to superiors.

Qualifications

• B.Tech/ B.E in Biomedical, Instrumentation, Electronics, or Mechanical Engineering.
• 3 to 4 years of production experience in IVD medical device manufacturing.
• Knowledge of ISO 13485 and GMP compliance requirements.
• Strong problem-solving and troubleshooting skills.
• Proficiency in MS Office and documentation handling.

Why Join Us?

• Opportunity to work with advanced RT-PCR medical device technology in the IVD sector.
• Collaborative work environment with exposure to cross-functional teams (QA/QC, Regulatory, Supply Chain).
• Professional growth through continuous learning and improvement initiatives.
• Be part of a mission-driven team ensuring quality healthcare solutions.

If this role excites you, let's connect!