Our client, a MedTech company, is currently looking for a Medtech Mechanical Project Manager.
Lead the system and subsystem acceptance activities.
In charge of the testers and test benches implementation projects in the manufacturing line of our surgical robot.
· Define the acceptance criteria and quality control requirements of our surgical robot at the system and subsystems (mechanical, electronics) levels in close collaboration with the R&D team.
· Generate the related specifications documentation.
· Develop and/or subcontract the development of testers in collaboration with external partners.
· Full project management of all the sub-projects with our contract manufacturer, suppliers and partners.
· Close follow-up of the implementation of the testers and IQ, OQ and PQ activities within our manufacturing line at contract manufacturer.
· Continuous improvement through process improvements.
· Maintain the technical documentation and records, including the DMR, up to date and aligned with regulatory requirements.
· Ensure compliance with our QMS and relevant norms and regulations. Contribute to establishing best practices.
· Proven track record in mechatronics and manufacturing automation.
· 5 years of relevant experience.
· Degree in microtechnology, robotics or mechanical engineering.
· Confirmed experience in multi-disciplinary project management including mechanical, electronics and software development.
· Software requirements: SOLIDWORKS, LabVIEW, MS Office, Altium Designer a plus.
· Knowledge of the ISO 13485. Machinery directive 2006/42/EC a plus.
· Versatile, all-purpose, hands-on, solution-oriented.
· Strong verbal and written documentation and communication skills.
· Fluent written and spoken English, French a plus.
· Open to travel – up to 10%, Europe.