Process Engineer

at  AP TECHNOLOGIES GROUP PTE LTD

• Develop and maintain the process documentation: Create and maintain detailed process documentation, including standard operating procedures (SOPs), work instructions, and process flowcharts. Ensure that manufacturing processes are well-documented and comply with relevant regulations and quality standards.
• Collaborate with cross-functional teams, including R&D engineers and production personnel, to select and implement appropriate equipment, tools, and technologies for manufacturing processes. This may involve evaluating equipment capabilities, conducting trials, and coordinating equipment validation activities.
• To design the test protocol and lead the process validation (IQ, OQ, PQ).
• Provide training and support to manufacturing personnel on current/new processes, equipment, and tools. Conduct training sessions, create training materials, and ensure that operators are knowledgeable about and follow established procedures.
• Identify and mitigate process-related risks that may impact product quality, safety, or compliance. Collaborate with the risk management team to implement risk assessment and mitigation strategies.
• Ensure adherence to relevant regulations and standards governing medical device manufacturing, such as ISO 13485 and FDA guidelines. Stay updated on regulatory requirements and participate in audits and inspections to maintain compliance.

JOB REQUIREMENTS:

• Bachelor’s Degree in Mechanical / Materials / Chemical Engineering or related disciplines.
• 2 to 6 years of relevant working experience preferably in medical device industry.
• Good process validation and process development knowledge and experience with strong analytical skills.
• Independent, resourceful, detail oriented, and self-motivated

Please refer the Job description for details