A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we’ve launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

We are seeking a highly skilled Senior Systems Engineer with a strong technical background to lead the development and innovation of our medical devices. This role requires a deep understanding of medical device engineering, regulatory compliance, and the ability to drive complex technical projects. In this position you will bridge the gap between technical teams and business stakeholders, ensuring that our products meet the highest standards of quality and compliance.

WHAT YOU WILL BE WORKING ON:

• Collaborate with the Product Management team to define user needs and product requirements and technically meet product manager expectations.
• Act as a liaison between technical teams and business stakeholders, effectively communicating product requirements and updates.
• Develop and maintain system requirements and specifications, ensuring alignment between user needs, product requirements, and technical specifications.
• Collaborate with cross-functional teams including engineering, design, regulatory affairs, quality assurance, and manufacturing to ensure seamless execution of projects.
• Ensure products meet all relevant regulatory requirements and quality standards. Work closely with regulatory affairs to navigate the approval process.
• Possess a deep understanding of medical device technologies, industry standards, and regulatory requirements. Stay abreast of emerging trends and technologies in the healthcare space.
• Stay up-to-date with medical device regulations and standards (e.g., FDA, ISO) and ensure that all products meet or exceed these requirements.
• Provide subject matter expertise in medical device engineering, including hardware, software, and systems integration. Guide the technical direction of projects, ensuring they meet industry standards and compliance requirements.
• Identify and mitigate technical risks associated with product development, ensuring that potential issues are addressed proactively.
  
  

ABOUT YOU:

• Bachelor's degree in engineering, computer science, or a related technical field. Master's degree or PhD is a plus.
• Proven track record of successfully leading complex technical projects in the medical device industry.
• Strong knowledge of medical device regulations and standards, including FDA and ISO requirements.
• Ability to lead cross-functional teams and drive results in a collaborative environment.
• Strong communication skills, with the ability to convey complex technical information to non-technical stakeholders.
• Ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
  
  

BENEFITS:

• Medical, dental, vision, life, and disability insurance
• "Take as much time as you need" policy
• Simple IRA plan with employer matching
• Company sponsored events and lunches
• Stipend for professional development
• Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring
  
  

Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.