Systems Engineer / Functional Safety Expert | Systems Engineer* / Functional Safety Expert* - Roche Mannheim
Franz & Wach Personalservice PEN
Job Summary
In this role at Roche Diagnostics, you will act as a key technical expert focused on the design verification and functional safety of medical devices. Your day-to-day responsibilities include developing and executing test methods from the early concept phase to final product release, creating robust test environments, and translating complex product requirements into actionable engineering specifications. You will serve as a subject matter expert, providing guidance on functional safety standards, supporting risk assessments, and mentoring junior colleagues and contractors. Additionally, you will collaborate with quality and product maintenance teams to investigate serial products and returns, ensuring all documentation adheres to strict regulatory standards. This position is ideal for an experienced engineer who thrives in a highly regulated environment and wants to contribute to the development of life-saving medical technology. You will play a pivotal role in shaping safety strategies and ensuring that all design verification processes meet both internal best practices and external international standards.
Required Skills
Education
Bachelor's or Master's degree in Engineering or Medical Technology.
Experience
- Professional experience in engineering or medical technology required.
- Demonstrated expertise in test and design verification of medical products.
- Proven experience in functional safety and decision-making based on regulatory standards and risk assessments.
- Experience in regulated environments relevant to medical device development.
Languages
Additional
- Work permit for Germany required. Role is offered via temporary employment agency (Franz & Wach) with the potential for direct hire at Roche Diagnostics.
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