Staff Systems Engineer
Sibel Health | Chicago, IL
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 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.
The Opportunity
We are seeking a highly-skilled Staff Systems Engineer to be a technical lead for product development activities from feasibility through post-market for our wearable sensors and medical monitoring system solutions. You will be responsible for system design, requirements management, system integration, verification and validation plans, and risk management activities. You will drive systems thinking and lead cross-functional teams to proactively identify and mitigate challenging technical topics. In this position, you will serve as the liaison between technical teams and business stakeholders, ensuring that our products meet the needs of our users while maintaining the highest standards of safety and quality.
This is a full-time position. The salary range for this role is $135,000 – $160,000, depending on level of experience.
What You Will Be Working On
- Support the planning, design, and execution of system engineering activities across the product lifecycle—from concept to post-market surveillance.
- Understand clinical and user needs and translate them into product requirements.
- Stay current with medical device technologies, regulations, and standards (e.g., FDA, ISO) to ensure compliance and product excellence.
- Manage overall requirements for product development projects, ensuring traceability to design outputs, verification, and validation activities.
- Develop and maintain test plans for System Integration, Verification, and Validation in close collaboration with the verification team.
- Create and manage Risk Management files, including Risk Management Plans, Reports, and Post-production Information Reports.
- Lead and/or coordinate FMEAs and perform impact assessments for proposed design or process changes.
- Support continuous improvement initiatives and promote best practices in a regulated environment.
- Teach and mentor junior team members.
About You
- Bachelor’s degree in engineering, computer science, or a related technical field (Master’s degree or PhD is a plus).
- 8+ years of systems engineering experience, including relevant experience in software, mechanical, and/or electrical disciplines.
- Experience designing complex medical devices in a regulated industry and familiarity with healthcare practices is preferred.
- Demonstrated knowledge of medical device regulations and standards, including FDA and ISO requirements.
- Proven experience leading cross-functional teams and driving collaborative results.
- Strong communication skills with the ability to convey complex technical information to non-technical stakeholders.
- Ability to thrive in a fast-paced, dynamic environment and effectively adapt to change.
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.