Systems Engineer - Remote

Overview

Artera is an AI startup focused on developing medical artificial intelligence tests to personalize therapy for cancer patients. We are looking for a Systems Engineer to lead various engineering activities across the product lifecycle, ensuring product safety, effectiveness, and compliance with regulatory standards.

In Short

• Lead requirements engineering processes across product and software teams.
• Manage software risk from development to post-market surveillance.
• Create and maintain system architecture documentation.
• Plan and execute usability testing activities.
• Support regulatory submissions and ensure compliance.
• Collaborate with cross-functional teams effectively.
• Utilize requirements management tools.
• Demonstrate strong technical writing skills.
• Work independently with minimal oversight.
• Adapt to a dynamic startup environment.

Requirements

• Bachelor’s degree in relevant engineering field.
• 5+ years of experience in systems engineering for medical devices.
• Strong knowledge of FDA, EU MDR, and ISO regulations.
• Expertise in requirements management and risk management.
• Experience with usability engineering compliance.
• Excellent documentation and communication skills.
• Ability to manage complexity across systems.
• Leadership and teamwork skills.
• Flexibility in a rapidly changing environment.
• Desire to build a new organization.

Benefits

• Opportunity to work in a cutting-edge AI startup.
• Contribute to meaningful healthcare solutions.
• Collaborate with a talented team of professionals.
• Flexible working environment.
• Potential for career growth and development.