- This topic has 0 replies, 1 voice, and was last updated 6 months, 1 week ago by .
Onera, Eindhoven and Palo Alto
Onera came out of HighTechXL’s 2017 cohort and has been growing ever since. In that time, the team – led by co-founders Soukaina Adnane and Ruben de Francisco – has been perfecting next-gen medical grade sleep diagnostics. This is a spin-off company of Leuven, Belgium-based R&D hub IMEC and Holst Centre, TNO’s R&D operations on High Tech Campus Eindhoven.
Onera raised 8.5 million euros in a Series A led by Jazz Pharmaceuticals, imec.xpand and includes imec and BOM. It just got it CE Mark in Europe for its Polysomnography (PSG) device.
Job openings include:
You will be involved in medical device compliance activities throughout the whole lifetime of our products.
You will be part of a multidisciplinary, energetic, young, and international start-up team. You will help to ensure that our products are in compliance with applicable medical device regulations and with our Quality Management System.
• Establish and maintain Onera’s Quality Management System (QMS)
• Establish and maintain the Quality policies
• Liaise with other managers and the Onera team, provide training, tools and techniques to enable others to achieve the quality objectives
• Follow-up and handling of Corrective and Preventive Actions (CAPAs) and QMS improvement opportunities
• Support internal and external audits
• Work with procurement staff to establish quality requirements/control for external suppliers
• Work with manufacturing staff to ensure that the manufacturing/production processes meet the quality standards
• Ensure good documentation practice
• BSc or MSc in life sciences, engineering or similar
• At least 4 years of relevant work experience
• At least 1 years in the medical device industry in quality assurance preferred
• Knowledge of ISO13485, 21 CFR 820
• Structured thinking, autonomous and ability to prioritize
• Skilled in numerical and statistical analysis
• Attention to detail
• Enjoy a dynamic, diverse, and flexible work environment
• Legally authorized to work in the Netherlands (already possessing a visa/EU residence permit)
• Good communication skills in English (written and spoken)
• Positive attitude, can-do mentality, and flexibility – much needed in a startup!
Apply by email to:
Onera has other openings including
• project manager, medical devices
• systems architect, medical devices
• embedded software engineer, medical devices
- You must be logged in to reply to this topic.