Process Engineer (Medical Devices)

Location: Gelang Patah, Johor, Malaysia; onsite in a cleanroom production environment for at least 80% of working time. Sunday or night-shift duty may be required depending on production tasks.

Company

hirify.global develops medical device technologies, including the OmniPod Insulin Management System and drug delivery platforms for pharmaceutical and biotechnology partners.

What you will do

• Support and implement process validation for new product introduction and process changes on the production line.
• Conduct engineering studies and builds, consolidate process data, and provide analysis and recommendations.
• Lead DMAIC activities for continuous improvement, product quality, and scrap reduction.
• Analyze machine-to-machine processes, material variation, process flow, capacity, and MES usage to improve manufacturing performance.
• Develop operator certifications, work instructions, manufacturing scorecards, and dashboards.
• Work with production, machine engineering, and cross-functional teams to troubleshoot issues and implement corrective actions, including production support when necessary.

Requirements

• Bachelor’s degree in engineering, preferably Mechanical, Electrical, or Industrial Engineering.
• At least 3 years of process or manufacturing engineering experience in a high-volume manufacturing environment.
• Knowledge of Six Sigma, Lean manufacturing, problem-solving, statistical analysis, and data-driven decision-making.
• Experience working in a cleanroom production environment and with automated production equipment.
• Multi-language fluency in English and Malay is required.
• Ability to work in a fast-paced production environment and collaborate in small and cross-functional teams.

Nice to have

• Familiarity with cGMP, EHS, ISO 13485, and FDA 21 CFR 820 requirements.
• Experience with CAD, ERP, MES, Spotfire, or Power BI.
• Experience debugging or maintaining automated discrete component assembly equipment.
• Knowledge of laser welding, heat staking, ultrasonic welding, ESD-sensitive devices, pFMEA, Quality Control Plans, or process validation.
• Experience in a start-up production environment.

Culture & Benefits

• Hands-on work in a high-volume medical device manufacturing plant.
• Regular collaboration with production and engineering teams to drive operational improvement.
• Performance-focused environment using manufacturing scorecards and dashboards.
• Work includes substantial time in a cleanroom and may involve Sunday or night shifts when required.