Biomedical / Biotechnology Engineer - Medical Device Manufacturing

Role & responsibilities

• Work on day to day production of medical devices in a clean, controlled environment
• Understand product specifications, drawings and quality requirements
• Monitor process parameters, yields and rejections and support continuous improvement
• Carry out in process and final inspection as per approved procedures
• Use basic measuring instruments for inspection and documentation
• Prepare and maintain batch records, inspection reports and other production/QA documentation
• Ensure that all activities comply with ISO 13485, ISO 14971, EU MDR and internal SOPs
• Co ordinate with Production, QA, Maintenance, Stores and Sterilization teams for smooth operations
• Assist senior engineers during internal and external audits by providing records and technical clarifications

Preferred candidate profile

• M E / M Tech in Biomedical Engineering or Biotechnology
• B E / B Tech in allied disciplines such as Electronics / Instrumentation / Mechanical may be considered only if the candidate has prior experience in medical device manufacturing, QA or testing

Technical skills

• Basic understanding of medical device lifecycle and risk management concepts
• Exposure to quality systems such as ISO 13485, ISO 14971, EU MDR is desirable
• Ability to read basic engineering drawings and follow work instructions and SOPs
• Good documentation habits and comfort with Excel/Word for recording data and preparing reports

Soft skills and other requirements

• Strong sense of responsibility, attention to detail and discipline in following procedures
• Willingness to work in a regulated manufacturing environment rather than a purely hospital role
• Good communication skills to interact with production operators, supervisors and management
• Candidates residing in or willing to relocate to Ambernath, Badlapur, Kalyan, Dombivli or nearby areas
• Preference for candidates looking for a stable, long term role in medical device manufacturing