Company Description
WISE is an innovative medical device Company focused on developing the next generation of implantable leads for neuromonitoring and neuromodulation using its proprietary Supersonic Technology. These highly ergonomic, conformable, soft, and thin electrodes provide excellent adhesion, minimal invasiveness, and great adaptability to different nervous tissue.
Role Description:
To support the development of new products, we are looking for a Qualification & Testing Engineer who will be part of R&D team; the new resource should bring to the team a solid expertise in the qualification of class III medical devices.
The role requires the ability to work in a team, with frequent collaborations with Regulatory, R&D, Production and Quality Departments, to ensure products quality and compliance with regulatory standards.
This is a full-time hybrid role, based in Cologno Monzese facility.
Main Responsabilities:
* Development of testing procedures and protocols for medical devices, ensuring compliance with applicable regulatory standards.
* Execution of tests on medical devices using appropriate setups, tools, and testing technique
* Analysis of test results, identification of any anomalies or defects, and collaboration with the development team to determine the root causes of failures.
* Accurate documentation of test results and preparation of test reports.
* Review of test protocols and reports conducted at external laboratories.
* Ensure the compliance to ISO 13485 standard and FDA/CE requirements, specific for class III medical devices
Requirements:
* MSc in Industrial Engineering (Materials, Biomedical, Mechanical, Aerospace, Electronic, Chemical are preferred) or MSc in Chemical or Physics; PhD is considered a plus.
* Not less than 3 years of experience in Qualification or Testing Department, b
ackground in the medical device or pharmaceutical sector is considered a plus
* Mandatory: knowledge of metrology, statistic and validation methods
* Knowledge of medical devices standards (ISO 13485, FDA 21 CFR 820)
* Fluency in both spoken and written Italian and English is required
* Strong analytical skills, problem solving and attention to detail
* Teamwork oriented and with strong communication skill
Proposal:
1 year of temporary employment contract, with real possibilities of a permanent transiction. Salary will be linked to real experience,