Officer / Sr. Officer

Meril GmbH; India; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Meril, an India-based medical device manufacturer, seeks a Biomedical/Production engineer to drive the day-to-day manufacture of urology devices and ensure documentation and quality systems are followed.

You will coordinate with QA/QC, R&D, Eng., and Supply Chain; maintain BMRs; monitor yield and line performance; support IQ/OQ/PQ and product transfers; and mentor operators while upholding 5S and cleanroom discipline.

Qualifications

• Bachelor's degree in Biomedical/Mechanical/Production Engineering or related field.
• 1-5 years of experience in medical device manufacturing.
• Experience with ISO 13485 and GMP.
• Good Documentation Practices (GDP) required.
• Lean manufacturing and 5S experience.

Responsibilities

• Execute day-to-day manufacturing of urology medical devices.
• Prepare Batch Manufacturing Records (BMR) and production documentation.
• Ensure ISO 13485, GMP, and QMS compliance.
• Coordinate with QA, QC, R&D, Engineering, and Supply Chain for smooth production.
• Monitor production output, yield, rejection, and machine utilization.
• Support process validation (IQ/OQ/PQ) and manufacturing transfers from R&D.
• Implement process improvements to enhance productivity and reduce waste.
• Ensure line clearance, traceability, and product identification throughout manufacturing.
• Participate in deviation, CAPA, NCR, and root cause investigations.
• Train operators on manufacturing procedures and GDP.
• Maintain 5S, safety, and cleanroom discipline in production areas.

Skills

Lean manufacturing

5S

GMP

ISO13485

GDP

Root cause analysis

ERP/SAP

Excel

Cross-functional collaboration

Ownership

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Production Engineering

Tools

SAP/ERP

Excel

Production reporting

Documentation tools

Job description

DELIVERINGWORLD-CLASS HEALTHCARE SOLUTIONS

Founded in 2006, Meril is an India-based, global medical devicecompany that is dedicated to the innovation, design and developmentof novel, clinically relevant and state-of-the-art devices. Ourfundamental aim is to champion the alleviation of human sufferingand improve quality of life. To enable this, we are committed toR&D, innovation in manufacturing medical technology, scientificcommunication, and contemporary distribution avenues.

Meril was born with the aim of improving the quality of humanlife through innovative and advanced healthcare solutions. As a medical device manufacturer, we exist to improve the inventivenessin healthcare so that people’s lives are enriched. We continuallyseek excellence in providing answers to some of medicine’s toughest questions.

Meril manufactures medical solutions in the form of vascularintervention devices, orthopaedic supplements, in‑vitro diagnostics,endo-surgery and ENT products. It is our core commitment to ensurethe delivery of advance healthcare solutions. Our inclinationtowards research and development is reflected in our diverseofferings. We ensure that we adhere to the best quality of standardsin manufacturing, scientific communication and distribution todeliver path-breaking healthcare products to the world.

We collaborate with physicians and global innovators to identifyunmet clinical needs and develop revolutionary therapies. Weencourage research and academic collaborations and remain availableto interact on exciting opportunities.

Headquartered in India with a manpower of more than 4000, Merilcurrently conducts business in more than 100 countries. We have 100%subsidiaries in India, USA, Germany, Brazil, Russia, South Africa,Bangladesh and Turkey. We have set up operations in China and Japan too.

Job Description

Key Responsibilities

• Execute day-to-day manufacturing of urology medical devices.
• Prepare and maintain Batch Manufacturing Records (BMR) and production documentation.
• Ensure compliance with ISO 13485, GMP, and company Quality Management System.
• Coordinate with QA, QC, R&D, Engineering, and Supply Chain for smooth production.
• Monitor production output, yield, rejection, and machine utilization.
• Support process validation (IQ/OQ/PQ) and manufacturing transfers from R&D.
• Implement process improvements to enhance productivity and reduce waste.
• Ensure line clearance, traceability, and product identification throughout manufacturing.
• Participate in deviation, CAPA, NCR, and root cause investigations.
• Train operators on manufacturing procedures and good documentation practices.
• Maintain 5S, safety, and cleanroom discipline in production areas.

Requirements

Educational Qualification

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Production Engineering, or related discipline.

Preferred: 1-5 years of experience in medical device manufacturing.

Technical Skills Required

• ISO 13485 & GMP
• Good Documentation Practices (GDP)
• Process Validation (IQ/OQ/PQ)
• Lean Manufacturing & 5S
• Root Cause Analysis (5 Why, Fishbone)
• SAP/ERP production transactions
• Microsoft Excel & production reporting
• Strong analytical and problem-solving ability
• Cross-functional collaboration
• Ownership and accountability

Hiring this role will provide the following benefits:

• Increase manufacturing capacity for the expanding Urology Solutions portfolio.
• Reduce production bottlenecks and improve on-time order fulfillment.
• Strengthen compliance with ISO 13485 and regulatory manufacturing requirements.
• Improve process efficiency, yield, and overall equipment utilization.
• Support successful transfer of new products from R&D into commercial manufacturing.
• Enhance documentation accuracy and reduce deviations, NCRs, and rework.
• Enable scalable production for CE, RoW, and future global market expansion.