Job Description

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 to lead product development activities from feasibility through post-market for our wearable sensors and medical medical monitoring system solutions. You will be responsible for system design, requirements management, system integration, 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 great opportunity to join a diverse, innovative, and passionate team that shares a common vision to provide Better Health Data for All®.

WHAT YOU WILL BE WORKING ON:

• Lead the planning, design, and execution of system engineering activities from concept to post-market surveillance for one of our medical device products.
• Collaborate with Product Management and Commercial teams to understand clinical and user needs and apply them to product realization.
• Stay up-to-date with medical device technologies, medical device regulations and standards (e.g., FDA, ISO) and ensure that the products meet or exceed these requirements.
• Collaborate with cross-functional teams including engineering, UI/Ux, regulatory affairs, quality assurance, and manufacturing to ensure seamless execution of projects and provide technical direction and expertise.
• Responsible for overall requirements management plan and process for product; develop and maintain system requirements, including traceability to product requirements, design outputs, and verification and validation.
• Support the development of requirements and traceability for different disciplines such as Software, Electrical, Mechanical, and others.
• Collaborate with V&V Engineers to develop and maintain test plans for System Integration, Verification and Validation and supervise testing, analysis, and integration activities.
• Create and manage Risk Management files, including Risk Management Plan, Hazard Analysis, and Risk Management Report.
• Lead and/or coordinate FMEAs.
• Perform requirements and risk management file impact assessments for any proposed design/material/process change or field complaint or manufacturing issue.

ABOUT YOU:

• Bachelor's degree in engineering, computer science, or a related technical field. A master's degree or PhD is a plus.
• 5+ years systems engineering experience including a minimum of 2 years as a systems engineer project lead in system or subsystem design. Will consider similar experience in software, mechanical, and/or electrical disciplines.
• Experience designing complex medical devices in regulated industry and knowledge of healthcare practices is preferred.
• Demonstrated knowledge of medical device regulations and standards, including FDA and ISO requirements.
• Experience leading cross-functional teams and driving 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 can 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.
• Yearly 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.

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