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Your role:
You're the right fit if you have :
Bachelors or Master's degree in Electrical Engineering or equivalent relevant degree.
A solid track record in creating audit-proof documentation.
The ability to absorb large amounts of information and compress that into understandable bite-sized clear and succinct documents for both technical and non-technical stakeholders.
Experience with releasing (Medica Device) Products to the market, from conception to full scale production and life cycle management.
A minimum of 15 years of experience in designing and testing electronics system elements or parts. Experience in the Medical Device industry would be nice to highly preferred.
Prior experience in engineering quality in the context of medical device development (documentation, traceability, sourcing) and quality systems.
Familiarity with Basic Safety 60601-1, Quality Management 13485, and risk management standards 14971 for Medical Devices
Experience using laboratory tools equipment such as oscilloscopes and soldering stations, etc.
High quality standards and a drive for continuous improvement
Taking ownership with a pro-active mindset and eager to learn.
Tool experience: knowledge of PLM database(s) (i.e. Windchill is a plus) and requirements/test case management tools (e.g. DNG, Doors) and proficiency in MS Office suite
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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