Kerja Sepenuh Masa, Process Engineer di Renrui HR Johor - Maukerja

Process Engineer (Medical Device Industry)

Work address: Senai Airport City, Senai, Johor, Malaysia.

Job Responsibilities

1. Develop, optimize, and standardize manufacturing processes for medical devices/consumables to ensure process stability, traceability, and compliance.
2. Lead New Product Introduction (NPI), including DFM review, process development, IQ/OQ/PQ validation, pilot run, mass production ramp-up, and handover.
3. Develop and update SOPs, Control Plans, PFMEA, and inspection specifications in compliance with ISO13485/ISO9001 and medical regulations.
4. Address process deviations and non-conformities; conduct RCA, CAPA, and mistake-proofing to improve yield and reduce rework/scrap.
5. Manage evaluation, acceptance, maintenance, and validation of tooling and equipment to meet medical production precision and cleanliness requirements.
6. Collaborate cross-functionally with production, quality, R&D, procurement, and suppliers to drive continuous improvement and cost optimization.
7. Maintain complete process/production records and support internal/external audits to ensure document compliance and process traceability.

Job Requirements

1. Diploma or above in Mechanical, Mechatronic, Manufacturing, Automation, or Biomedical Engineering.
2. Minimum 2 years of PE/NPI experience in medical device/consumable industry; experience in precision assembly, injection molding, or electronic assembly is preferred.
3. Familiar with medical device NPI full cycle, process validation, cleanroom management, traceability system, and ISO13485/ISO9001.
4. Proficient in RCA/8D/CAPA, SOP/Control Plan/PFMEA development, DFM review, and statistical data analysis.
5. Ability to independently resolve on-site process issues; strong compliance awareness and cross-functional coordination skills.
6. Skilled in MS Office and data analysis/reporting; experience in medical device validation or cleanroom manufacturing is preferred.
7. Responsible, good communication, able to work under pressure, with strong continuous improvement and quality compliance mindset.