job description
Are you a skilled Process Engineer with expertise in medical device manufacturing? Join a leading precision manufacturing company in Bali and play a pivotal role in optimizing production processes, ensuring quality, and driving innovation in the medical device industry.
In this role, you will collaborate with cross-functional teams to enhance manufacturing efficiency, implement best practices, and maintain compliance with industry standards. If you are passionate about engineering excellence and thrive in a dynamic environment, this is the perfect opportunity for you.
Bali offers a unique blend of professional growth and work-life balance, making it an ideal location for ambitious engineers looking to advance their careers while enjoying a vibrant lifestyle.
Responsibility
- Develop and optimize manufacturing processes for medical devices to improve efficiency and quality.
- Collaborate with R&D and production teams to implement process improvements and innovations.
- Ensure compliance with industry regulations, including ISO 13485 and FDA standards.
- Conduct process validation, risk assessments, and troubleshooting to resolve production issues.
- Lead continuous improvement initiatives using Lean and Six Sigma methodologies.
- Train and mentor production staff on best practices and safety protocols.
- Monitor and analyze production data to identify trends and areas for optimization.
- Work closely with suppliers and vendors to ensure material quality and process consistency.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related field.
- Minimum 3 years of experience in process engineering, preferably in medical device manufacturing.
- Strong knowledge of GMP, ISO 13485, and FDA regulations.
- Experience with process validation, SPC, and root cause analysis.
- Proficiency in CAD, SolidWorks, or similar engineering software.
- Excellent problem-solving and analytical skills.
- Strong communication and teamwork abilities.
- Certification in Lean Six Sigma is a plus.