We are seeking a highly skilled and detail-oriented Senior Production Engineer – Medical Devices to lead and optimize manufacturing operations for our medical devices division. The role involves supervising production processes, ensuring compliance with regulatory standards (like ISO 13485, FDA), driving continuous improvements, and collaborating with cross-functional teams to meet quality, efficiency, and delivery targets.
Key Responsibilities:
Supervise day-to-day manufacturing activities ensuring adherence to production schedules and quality standards.
Develop, implement, and optimize production processes and workflows for medical equipment manufacturing.
Ensure all production processes comply with GMP, ISO 13485, and FDA regulations.
Lead and support root cause analysis, corrective and preventive actions (CAPA), and non-conformance investigations.
Coordinate with design, quality, supply chain, and maintenance teams to ensure seamless production flow.
Train and mentor junior engineers and production operators.
Monitor and analyze production metrics (OEE, yield, downtime) and implement continuous improvement strategies.
Manage documentation related to production processes including SOPs, work instructions, and validation reports.
Assist in equipment installation, qualification, and maintenance planning.
Support internal and external audits by providing necessary documentation and process details.
Qualifications:
Diploma/ITI/Bachelor’s Degree in Mechanical, Biomedical, Electrical, or Industrial Engineering.
Minimum 5 years of experience in a regulated medical device manufacturing environment.
Strong knowledge of GMP, ISO 13485, and FDA QSR requirements.
Hands-on experience with lean manufacturing, Six Sigma, and root cause analysis tools.
Proficiency in ERP systems and production planning tools.
Excellent problem-solving, communication, and leadership skills.