Industrialization engineer (single use Instruments and accessories)
Distalmotion SA, Switzerland
Job Description
About us
At Distalmotion, we believe 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.
You are looking for a new fulfilling challenge in a fast-growing medical device company? Join a team engaged in making on-demand robotic surgery the new medical revolution.
About Industrialization engineer
In this role you will support the industrialization, continuous improvement, and manufacturing ramp-up of Distalmotion’s single use instruments and accessories.
Tasks
- Support the industrialization, the design transfer and manufacturing of our single use instruments and accessories and their components in close partnership with contract manufacturers and suppliers
- Lead Manufacturing Change Request with RnD and suppliers
- Support the volume ramp up of the instrument manufacturing line
- Participate in maintaining technical documentation up to date including Device Master Records (DMR) through a PLM (Product Life cycle) software
- Develop manufacturing tooling and manufacturing processes
- Participate in the continuous update of risk management Failure Mode Effect Analysis (FMEA)
- Participate in the writing and review of protocols for equipment qualification and process validation such as Design, Installation, Operational and Performance Qualification (DQ, IQ, IQ, PQ)
- 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
Requirements
- Degree in engineering (microtechnology, robotics, mechanical engineering or equivalent)
- Minimum 5 years of experience in industrialization and manufacturing of medical devices
- Proven track record in industrialization and/or manufacturing line follow-up (project management a plus)
- Experience in tooling and manufacturing process development
- Experience in semi-complex assembly in high volumes
- Experience in equipment / process qualification (injection, welding, precision machining, assembly, cleaning.)
- Experience in multi-disciplinary Supplier coordination
- Experience in a manufacturing site, ideally in a controlled environment
- 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 eg. Polarion) or ERP software a plus
- Knowledge of the ISO 13485; Regulation (EU) a plus : 2017/745 (MDR) (93/42/EEC (MDD))
- Strong verbal and written documentation and communication skills
- Fluent written and spoken English and French, German a plus
- Open to travel up to 10%, Europe
Benefits
- Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.
- Permanent contract with 25 days of paid vacation.
- A dynamic atmosphere in an internationally minded environment.
- Flexible work schedule (possibility to regularly work from home).
- Other benefits : Mobility plan, competitive company pension plan, support for gym memberships.
- Regular team building events such as boot camps, skiing and much more.
Distalmotion is a medical device company founded and based in Lausanne, Switzerland. It was founded in 2012, as a spin-off from the Robotics Lab of the Swiss Federal Institute of Technology in Lausanne (EPFL).Our objective is to remove the complexity out of robotic surgery in order to fast track its widespread adoption in minimally invasive care. To do so, we want to continue disrupting minimal invasive surgery - but we will only succeed with the right people on our team. Join our team to address critical healthcare needs and improve patients’ lives !
For further information visit: dexter.surgery and follow us on LinkedIn/Twitter: @Distalmotion.