Lead System Engineer

at  Pixieray

We are now looking for a Lead System Engineer to join our team of experts in shaping the future of our cutting-edge medical devices, contributing to their success from conception to certification. If you’re ready to make a meaningful impact and get involved hands-on in the intersection of engineering, compliance, and innovation, we invite you to apply and be a driving force in our exciting journey!

Responsibilities:

• Product Specification Expertise: Actively participate in the R&D process, translating specifications into precise medical requirements aligned with industry standards.
• Device Compliance Ownership: Take the lead in ensuring seamless integration and adherence to regulatory standards within the R&D team.
• Lead Testing Initiatives: Drive external usability and clinical testing, overseeing safety documentation and technical requirements.
• External Collaboration: Work closely with external bodies and test houses to facilitate thorough product testing and certification, ensuring compliance with regulatory requirements.
• QMS Process Definition: Support and define Quality Management System (QMS) processes related to documentation, records, and testing, contributing to high product quality and compliance standards.

• Product Specification Expertise: Actively participate in the R&D process, translating specifications into precise medical requirements aligned with industry standards.
• Device Compliance Ownership: Take the lead in ensuring seamless integration and adherence to regulatory standards within the R&D team.
• Lead Testing Initiatives: Drive external usability and clinical testing, overseeing safety documentation and technical requirements.
• External Collaboration: Work closely with external bodies and test houses to facilitate thorough product testing and certification, ensuring compliance with regulatory requirements.
• QMS Process Definition: Support and define Quality Management System (QMS) processes related to documentation, records, and testing, contributing to high product quality and compliance standards