This engineering position is dedicated to the development, optimization, validation and industrialization of cost effective manufacturing processes for intravascular catheters. It requires therefore a strong interaction with quality, manufacturing and the RD in charge of the development of delivery systems, to achieve the expected process yields,
costs and capacity.
TASKS AND RESPONSIBILITIES:
? Develop, optimize, validate and industrialize reliable and cost effective manufacturing processes for
intravascular catheters in order to meet the yields, costs and capacity expectations;
? Propose design modification when appropriate and support design verification accordingly;
? Design, order and qualify tools and equipment to rationalize the manufacturing operations;
? Develop and document internal in-vitro test procedures, realize bench tests and statistically analyze results;
? Prepare the manufacturing documentation for new products
? Support and train the Operations department during the manufacturing of devices for RD purposes e.g.
verification & validation samples for new product developments, production ramp-up;
? Minimum of two years in medical device manufacturing, ideally involving intravascular catheters
? Knowledge in the following fields:
- Process development and validation;
- Quality system ISO 13485;
- Risk management;
- 6 Sigma and statistical process control;
- Adhesive bonding and polymeric welding processes;
- 3D CAD.
? Degree (BSc or equivalent) in mechanical, micro-technical, biomedical or process engineering.
? Team oriented;
? Entrepreneurial spirit, committed to moving projects forward;
? Flexible (able to work in a fast-evolving environment);
? Ready for "hands-on" activities;
? Fluent in French, ability to communicate in English (written, spoken), German is an asset
? Able to communicate and train the manufacturing operators;
? Able to understand the design and use of complex medical devices and the impact of manufacturing process
on the product performances;