Operations & Service Engineer - Medical Devices
The successful candidate will lead hardware manufacturing and servicing activities, ensuring the delivery of product and hardware asset management activities, compliance with standards and regulations, world-class manufacturing performance, cost efficiency, and continuous improvement initiatives.
The role involves technical leadership in manufacturing transfer and ramp-up of new and existing products, development and implementation of field service capabilities, management of quality processes, contribution to departmental and company goals, and support for business partners through technical leadership and project execution.
Key Responsibilities:
* Technical leadership in manufacturing transfer and ramp-up of new and existing products, supporting manufacturing transitions using design for manufacturability principles.
* Development and implementation of field service capabilities, including installation, servicing, and repair of medical devices onsite at clinical sites and third-party repair centers.
* Management of quality processes, including NCMRs, CAPAs, supplier monitoring, audits, risk management, and internal controls, ensuring compliance with ISO 13485 and other relevant standards for medical devices.
Requirements:
* Bachelor's degree in engineering or related field, with at least 10 years of experience, including 5 years in a technical leadership role within the medical device industry.
* Experience working within ISO 13485/FDA regulated quality systems, with understanding of risk management methodologies.
* Proven track record in manufacturing and field service in a regulated environment; experience with medical device catheter products is a plus.
Benefits:
We offer a dynamic work environment, international culture, flexible working arrangements, and opportunities for professional growth and development. Our team is passionate about delivering innovative medical devices that benefit patients and improve healthcare outcomes.