About OrbusNeich – Pioneers in life-changing technologies
OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products are the world's first dual therapy stent, the COMBO Dual Therapy Stent, and the world’s first pro-healing stent, the Genous™ Stent. Other products include coronary stents and balloons marketed under the names of Azule™, Scoreflex™, Sapphire™ II, Sapphire™ II Pro, Sapphire™ II NC and peripheral balloons JADE™ and Scoreflex™ PTA . OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.
Objective of the job
The Manager Engineering and IT is responsible for leading the Information Technology and Engineering Departments at OrbusNeich Medical B.V. This includes the transfer, setup and maintenance of production lines.
Key tasks of the job
- Manage facilities, cleanroom and production areas
- Maintain existing production processes
- Coordinate daily support of production
- Coordinate NCMR’s and CAPA as needed
- Maintain production and facilities monitoring databases
- Responsible for maintenance of applicable manufacturing and product development related documents
Tooling and Calibration
- Oversee and maintain tool control system
- Coordinate the IT infrastructure in the BV
- Coordinate IT projects together with BV staff and consultants
- Maintain an overview of current and future IT projects and decide on priorities together with the BV management team and the Worldwide IT Manager.
- Coordinate BV IT infrastructure, projects, policies and procedures with the WW IT Manager.
Supervision and representation
- Supervising the Engineering Department and Information Technology Department
- The Manager Engineering and IT is the primary contact for engineering and IT tasks and projects within the BV
- Coordinate Engineering and IT efforts with other production sites
Additional functions/Deputy tasks
- Capable of managing complex projects within a highly regulated industry
- College Degree in Engineering or equivalent
- Interest in microbiology and sterilization a plus
- Minimum of five years of experience in mechanical or systems engineering (medical device sector is a plus but not required)
- Firm and independent personality
- Good knowledge of English language
- Knowledge of AutoCAD is a plus
- Knowledge of Lean Manufacturing techniques is a plus