What you'll do
Manage the laboratory for the R&D Disposable Kit Team,
Support new lab equipment investment, Lab layout and Lab organization: manage URS, SRS, SAT, FAT, Utilities, IQ, Gage R&R, WI, equipment documentation, training materials and training.
Maintain Lab Equipment: manage calibration, maintenance, supplies, spare parts and wastes.
Support root cause analysis, Verification and Validation activities regarding equipment needs, test methodologies setup and internal test execution or via external laboratories under the supervision of the Verification & Validation engineers.
Work in close collaboration with other R&D functions, suppliers, production, supply chain and quality for manufacturing prototypes series (workshop, internal or contractor production builds).
Support laboratory audits to demonstrate compliance to ISO13485.
As member of the EHS committee for R&D Team, participate to EHS audits and organize, support all activities to comply with EHS policies.
Who you are
Engineering Technician (AAS degree, or Certificate) equivalent in physics, mechanics, electronics, or similar field.
Minimum 5 year-experience in medical device/IVD/Life Science industry and/or in Laboratory equipment management (IQ, Gage R&R, Calibration, Maintenance,) with knowledge for instance of ISO13485.
Experience with supporting laboratory activities for R&D and/or supporting Manufacturing Engineering and/or Production Line.
Strong communication skills.
Highly motivated, independent, detail-oriented and well-organized, you have the ability to collaborate and operate in a multinational environment.
Creative, agile, with good issue solving skills, you are always eager to learn. Delivering on-time according to high quality standards is your motto.
Experience preferred, but not required: Project management and Statistical data analysis. Familiar with PLCs, LabView and environmental chambers. Finally: Yellow or Green Belt certified with experience in 5S implementation.