job description
Join Haemonetics, a global leader in blood management solutions, as a Senior Manufacturing Engineer in the vibrant hub of Denpasar, Bali. This is your opportunity to drive operational excellence in medical device manufacturing by developing cutting-edge processes, leading validation initiatives, and ensuring quality, compliance, and cost-efficiency at every stage of production.
In this high-impact role, you will collaborate with cross-functional teams to optimize manufacturing workflows, implement lean methodologies, and maintain the highest standards of regulatory compliance (ISO 13485, FDA, CE). Your expertise will directly contribute to the delivery of life-saving technologies that improve patient outcomes worldwide.
Bali offers a unique blend of professional growth and work-life balance, with its dynamic business ecosystem and unparalleled lifestyle amenities. Whether you're based in Canggu, Ubud, or Denpasar, you’ll thrive in an environment that values innovation, sustainability, and community.
Responsibility
- Lead the design, development, and optimization of manufacturing processes for medical devices, ensuring scalability and efficiency.
- Spearhead process validation (IQ/OQ/PQ) and risk management activities in compliance with global regulatory standards.
- Collaborate with R&D, Quality, and Operations teams to translate product designs into manufacturable solutions.
- Implement lean manufacturing and Six Sigma principles to reduce waste, improve yield, and enhance productivity.
- Develop and maintain standard operating procedures (SOPs), work instructions, and training programs for production staff.
- Monitor key performance indicators (KPIs) and drive continuous improvement initiatives to meet cost, quality, and delivery targets.
- Ensure adherence to GMP, ISO 13485, FDA 21 CFR Part 820, and other relevant quality systems.
- Troubleshoot production issues, perform root cause analysis, and implement corrective actions (CAPA).
Qualifications
- Bachelor’s degree in Mechanical, Industrial, Biomedical Engineering, or a related field. Master’s degree preferred.
- Minimum 7+ years of experience in manufacturing engineering, with at least 3 years in medical devices or regulated industries.
- Proven expertise in process validation, DFM/DFA, and statistical process control (SPC).
- Strong knowledge of regulatory requirements (ISO 13485, FDA QSR, CE Marking).
- Experience with ERP/MES systems (e.g., SAP, Oracle) and CAD/CAM tools (SolidWorks, AutoCAD).
- Certification in Six Sigma (Green Belt/Black Belt) or Lean Manufacturing is a plus.
- Excellent problem-solving, project management, and cross-functional leadership skills.
- Fluency in English; proficiency in Bahasa Indonesia is advantageous.