System Engineer

We are a dynamic start-up company at the forefront of innovation in the medical field. Our mission is to develop cutting-edge medical devices that contribute to advancements in healthcare. As we expand our team, we are seeking an experienced Medical Device Systems Engineer to play a pivotal role in the development, integration, and validation of our groundbreaking products.

Position Overview:

As a Medical Device Systems Engineer V&V :

you will be a key member of our development team, contributing to all stages of the product lifecycle. This includes writing technical documents, executing systems integration and verification plans, and managing and updating the Design History File (DHF). Your expertise will be crucial in ensuring our products meet regulatory standards and obtain necessary approvals.

Responsibilities:

• Participate in all stages of development, from concept to commercialization.
• Write technical documents, including specifications, design documents, and test protocols, ensuring compliance with regulatory requirements.
• Execute systems integration and verification plans, overseeing all test phases and troubleshooting issues as they arise.
• Manage and update the Design History File (DHF) to ensure accurate and comprehensive documentation throughout the development process.
• Collaborate with cross-functional teams, including software and hardware engineers, to achieve project milestones and deliver high-quality products.

Requirements:

• 3-5 years of experience as a medical device systems engineer.
• Proven experience in systems development, including writing technical documents and specifications.
• Strong background in validation testing and verification processes.
• Bachelor's degree in engineering or software engineering.
• Previous experience in writing and submitting for MDR, FDA, and CE approvals.
• Familiarity with regulatory standards and compliance in the medical device industry.

GOOD-LUCK