Let's Talk about the Role:

We are seeking a Systems Engineer with a strong foundation in engineering principles and a demonstrated ability to apply AI and data-driven tools to improve complex development and operational processes. In this role, you'll work across cross-functional teams to ensure our medical devices meet technical, user, and regulatory requirements-while also driving innovation through smarter, AI-enabled systems and workflows.

If you're passionate about systems thinking and enjoy leveraging AI to enhance product development, streamline operations, or support better decision-making, this is a great opportunity to make a meaningful impact.

Let's Talk about Key Responsibilities:

• Lead and contribute to systems engineering activities across the product lifecycle-from early concept through design, verification, and post-market support.
• Develop and maintain system requirements, architecture, and interface definitions with an emphasis on traceability and regulatory compliance.
• Integrate AI/ML tools to optimize processes such as requirements management, verification and validation planning, change management, root-cause analysis, and design iteration.
• Use data analytics and automation to improve engineering efficiency, reduce risk, and identify trends or areas for process refinement.
• Collaborate closely with cross-functional teams (design, quality, regulatory, manufacturing) to ensure technical alignment and robust product integration.
• Contribute to documentation and technical justifications for regulatory submissions and audits.
• Conduct risk assessments and manage system risk analysis to ensure safety, effectiveness, and regulatory alignment.
• Support continuous improvement initiatives focused on systems engineering processes and tools, including those enhanced by AI.

Let's Talk about Qualifications and Experience:

• Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
• 3-5 years of experience in systems engineering or a closely related discipline, ideally in a regulated industry.
• Hands-on experience using AI or machine learning to solve engineering or operational challenges-e.g., model development, data classification, predictive analytics, or workflow automation.
• Familiarity with system requirements tools and methodologies (e.g., DOORS, Jama), as well as basic data science platforms (e.g., Python, Jupyter, MATLAB).
• Strong problem-solving and technical communication skills.

Preferred:

• Advanced degree in Engineering, Data Science, or a related field.
• Experience in medical devices, diagnostics, or other regulated industries.