Support the technology transfer and manufacturing in close partnership with contract manufacturers
Support the ramp up of the Robot and accessories manufacturing
Follow up change management processes within both manufacturing line and pre-series manufacturing line.
Lead the refurbishing line of the field robots to bring them to the latest design version at our CMO
Follow up the repair center for robot modules and sub-modules
Participate in maintaining technical documentation up to date including Device Master Records (DMR) through a PLM (Product Life cycle) software
Ensure the Device History Records (DHR) are properly maintained with all robot configurations from manufacturing
Ensure compliance with relevant norms and regulations. Establish and maintain appropriate documents and records in compliance with company’s QMS.
Contribute to establishing best practices
Continuous improvement through process improvements
Degree in engineering (microtechnology, robotics, mechanical engineering or equivalent)
Proven track record in project management of mechatronics development, technology transfer (From R&D to production) and manufacturing lines follow up, including Supplier and CMO (Contract Manufacturing Organization) coordination
3 to 5+ years of proven experience with electromechanical Medical devices (IIa, IIb, III) manufacturing
Software requirements: basic knowledge of CAD SW (eg. SOLIDWORKS), MS Office, Altium Designer a plus. Any PLM (Product life cycle Management) software a plus
Knowledge of the ISO 13485. Machinery directive 2006/42/EC a plus.
Versatile, all-purpose, hands-on, solution-oriented, with strong verbal and written documentation and communication skills
English Fluent. French &/or German a plus
Open to travel – up to 10%, Europe