- Evaluate and analyze the electrical safety of medical device designs, identifying potential hazards and recommending mitigation strategies
- Own and maintain electric safety documents and standards
- Collaborate closely with cross-functional teams including R&D engineers, Project Managers, Product Marketing, Clinical Affairs, and regulatory specialists to ensure that safety considerations are integrated into product development from conception to launch
- Support on Failure Mode and Effects Analysis (FMEA) and document findings and recommendations to ensure that appropriate corrective and preventive actions are implemented throughout the product lifecycle
- Conduct thorough risk assessments and safety tests on prototypes and finished products, interpreting results and providing actionable recommendations
- Organize and coordinate testing with external partners for standard compliance
- Stay updated on industry standards, regulations, and emerging technologies related to electrical safety in medical devices and ensure that our products remain in compliance
- Act as a subject matter expert on electrical safety, providing guidance and training to internal stakeholders as needed
- Support the Quality Department during audits
- University degree in electrical engineering or equivalent
- 3+ years experience in applied electrical engineering, preferably in the medical industry
- Experienced in the application of relevant medical standards (IEC , UN38.3, IEC62133-2, UL1642
- Nice to have: General knowledge of IEC , -13 and IEC 60529
- Experience conducting electrical safety testing and risk assessments, including familiarity with testing methodologies and equipment
- Expertise in electrical circuits and power sources, Experience with power management of low power devices is a plus
- Experience with quality management systems and/or regulatory
- Strong analytical skills and attention to detail, with the ability to interpret complex technical data and make informed recommendations
- Willing to work in a distributed, diverse collaboration environment
- Fluent in oral and written communication skills English
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Electric Safety Expert - Stäfa, Schweiz - Sonova
Beschreibung
Research & Development delivers hearing solutions and services for hearing-impaired people, hearing care professionals, and further related people, in the form of hearing devices, accessories, web services, mobile applications, and PC software.
Developing and ensuring electrical safety compliance of medical devices is your passion. You have 3+ years of experience in development, possess applied knowledge of electric safety standards and are familiar with medical device regulations. Embedded in an international research and development team, you will support product creation by taking over responsibility for compliance with relevant electric safety regulations. By assessing and mitigating risks through design suggestions, you ensure that the electric safety of all our products is ensured at any time during their lifecycle.
Your tasks
Your profile
Our offer
We can offer you a new challenge, with interesting tasks and much more – including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles.
Employment level 80-100%.
Pascal Spycher, Talent Acquisition Manager, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.
