Systems Test Engineer – Product Safety

Systems Test Engineer – Product Safety

Join us in a role where you'll be an essential part of a world-class team of Systems Test Engineers dedicated to ensuring the safety and quality of our patient monitoring devices. Your contributions will directly impact our mission to save lives by providing high-quality, compliant products. This is a dynamic, challenging role within an organization that values continuous growth and innovation, offering you significant opportunities to develop your skills and explore new possibilities.

As part of our global Hardware Test Engineering team within the Hospital Patient Monitoring division, you'll report to a subgroup leader based in Boeblingen, Germany.

Your role:

• Serve as the subject matter expert on product safety standards, specifically IEC 60601-1 and IEC 60601-2-x, ensuring our products meet and exceed the highest compliance standards.
• Lead and manage complex system testing projects related to product safety, maintaining strict adherence to safety and regulatory requirements across multiple projects.
• Act as the primary liaison with external safety test agencies, ensuring precise and effective communication in all technical interactions.
• Develop and maintain comprehensive documentation of test procedures, results, and compliance records, setting industry benchmarks for thoroughness and accuracy.
• Guide cross-functional teams, integrating product safety considerations into every stage of product development, even when managing multiple competing priorities.

You're the right fit if:

• You have at least 5-10 years of industry experience, with a strong focus on system testing and product safety within the medical device sector.
• You possess deep knowledge of product safety standards, particularly IEC 60601-1, IEC60601-1-x, IEC/ISO 60601-2-xx and IEC/ISO80601-2-xx.
• You have deep knowledge and experience of relevant regulations (UL, FDA, CSA, IEC, GB etc.) and relevant standards (General Safety, EMI/EMC, Environmental etc.)
• Experience with patient monitoring devices is preferable. Knowhow of design control processes for medical device design. System thinking mindset and domain expertise in the related area
• You excel at managing and prioritizing multiple projects with conflicting demands, consistently delivering successful outcomes.
• You have outstanding communication skills, capable of engaging effectively with both technical and non-technical stakeholders.
• You are a proven leader in project management, with a track record of driving results in a complex, dynamic environment.
• You have an international perspective and are eager to collaborate with diverse cultures and backgrounds.
• Be structured and self-organized. Good team player and ability to work independently & act pro-actively.

How we work togetherWe believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. This role is an office role, where you will work from our Boeblingen office.

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.