Distalmotion believes that every patient undergoing minimal invasive surgery should benefit from the best of surgical expertise and robotic technology. This is the vision that made us create Dexter, the world’s first and only on-demand robotic surgery system. Thanks to Dexter, surgeons have never been closer to their patients while benefiting from robotic best-in-class technology.
Distalmotion has been created in 2012 by passionate and open-minded people with various experiences. Today, we are still convinced that an inclusive and international company culture is the best way to continue growing. Our leadership is highly committed to promote diversity among the teams and welcome every employee based on their identity.
About Manufacturing Engineer
Manufacturing engineering on our surgical instruments product line including: manufacturing process development and implementation, manufacturing transfer and cost engineering / reduction.
Tasks:
Manufacturing process development on existing product lines as well as new ones (NPI).
Support the continuous effort on the lean manufacturing line. Constantly improving it, removing wastes at a high level of quality.
Lead Manufacturing Change Request in collaboration with cross-functional team.
Lead the Manufacturing transfer activities (transfer, qualification, support).
Participate in maintaining technical documentation up to date including Device Master Records (DMR) through a PLM (Product Life cycle) software and ERP (Enterprise Resource Planning).
Participate in the improvements of test strategies for the components and the finished products.
Ensure compliance with relevant norms and regulations. Establish and maintain appropriate documents and records in compliance with Distalmotion’s QMS.
Manage relationships with suppliers and CMO (Contract Manufacturing Organization).
Ensure the development of mechanical or mechatronics devices: process development, industrialization (R&D to production) and / or manufacturing lines follow up
Lead / Participate to the investigations in case of manufacturing.
Contribute to establishing best practices in production.
Requirements:
Degree in engineering (microtechnology, robotics, mechanical engineering or equivalent)
Minimum 6 Years of experience in production or method/industrialization
Analytical mind, data and solution oriented
Cost of goods sold (COGS) breakdown structure calculation knowledge
Expert in data management in tool like; Excel (pivot tables, Macros), tableau, Power BI
Experience in equipment / process design dev. and qualification (Injection, machining, assembly, welding, gluing, cleaning....).
Experience in injection molding, plastic Ultrasonic Welding a plus.
Experience in sterile packaging, sealing a plus.
Proven experience with Medical devices (IIa, IIb, III) manufacturing. Sterile and Single use a plus.
Software requirements: basic knowledge of CAD SW (eg. SOLIDWORKS), MS Office, Any PLM (Product life cycle Management) and ERP (Enterprise Resource Planning).
Knowledge of the ISO 13485; Regulation (EU) a plus : 2017/745 (MDR) (93/42/EEC (MDD).
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