4 дня назад
Senior Automation Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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