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.
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Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.
