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4 дня назад

Senior Automation Engineer (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Malaysia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Senior Automation Engineer (Medical Devices): Designing, specifying, commissioning, and validating automated assembly and packaging equipment for wearable medical device manufacturing with an accent on machine design, robotics, packaging technologies, and cross-functional execution. Focus on leading IQ/OQ/PQ, FAT, and SAT activities, transferring equipment across global sites, coordinating vendors, and improving equipment reliability and capacity.

Location: Gelang Patah, Johor, Malaysia; onsite role with approximately 30% domestic and international travel

Company

hirify.global develops high-volume, disposable, electromechanical, wearable medical devices through its Omnipod product platform.

What you will do

  • Design, specify, procure, install, start up, commission, and validate automated assembly and packaging equipment.
  • Support current manufacturing operations, new product development, capacity expansion, technology transfers, and equipment obsolescence programs.
  • Lead IQ, OQ, PQ, FAT, and SAT activities for new automation technologies and equipment transfers.
  • Coordinate cross-site and cross-functional projects with manufacturing, quality, maintenance, supply chain, suppliers, and regional engineering teams.
  • Manage vendor communications, design reviews, project milestones, risks, resources, budgets, and capital project deliverables.
  • Provide technical leadership, mentorship, training, and continuous improvement support to engineers and vendor teams.

Requirements

  • Bachelor of Science in Mechanical Engineering; a master’s degree is a plus.
  • 6+ years of hands-on machine design experience.
  • Experience with automated discrete-component assembly or packaging technologies, equipment commissioning, debugging, and validation.
  • Strong mechanical aptitude and knowledge of machine design, pneumatics, linkage design, mechatronics, robotics, drive systems, PLC-based equipment, and vision systems.
  • Experience with packaging processes such as cartoning, bagging, sealing, conveyors, blister forming, ultrasonic welding, heat transfer decoration, hot stamping, laser welding, or laser decoration.
  • Proficiency with CAD modeling software, preferably SolidWorks, plus experience with data analysis and structured problem-solving tools.

Nice to have

  • Experience in regulated manufacturing or the medical device industry.
  • Knowledge of machine and process safety standards including CE, UL, SCCR, NFPA-70E, NFPA-79, DIN, ASME, or ISO.
  • Experience with Minitab or JMP, formal project management, and post-implementation continuous improvement methodologies.
  • Master of Science in Mechanical Engineering.

Culture & Benefits

  • Collaborative work across manufacturing, engineering, quality, metrology, suppliers, and multiple geographic locations.
  • Fast-paced, growth-oriented environment focused on innovative wearable medical devices.
  • Opportunity to lead global automation projects and develop the capabilities of engineers and project teams.
  • Travel is required according to business needs, estimated at approximately 30% domestically and internationally.

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