Officer / Sr. Officer

Meril Life Sciences; Valsad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Meril Life Sciences in Gujarat is seeking a Biomedical/Production Engineer to oversee day-to-day manufacture of urology medical devices, maintain batch records, and ensure ISO 13485 and GMP compliance.

You will coordinate with QA, R&D, and Supply Chain, drive process improvements, support IQ/OQ/PQ, and mentor operators in 5S and good documentation practices for scalable, compliant production.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Production Engineering, or related discipline.
• Preferred: 1–5 years of experience in medical device manufacturing.
• Knowledge of ISO 13485 & GMP is required.
• Strong problem-solving and documentation skills.

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.

Skills

Lean Manufacturing

5S

Root Cause Analysis

Cross-functional collaboration

Ownership & accountability

Analytical thinking

Education

Bachelor's in Biomedical Engineering

Bachelor's in Mechanical Engineering

Bachelor's in Production Engineering

Tools

SAP/ERP

Excel

Production reporting

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.