Staff Systems Engineer

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 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 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: 

• Support the planning, design, and execution of system engineering activities associated with one or more products in different stages of the product lifecycle from concept to post-market surveillance. 
• 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.
• Responsible for overall requirements management for specific product development projects. Develop and maintain system and subsystem requirements, including traceability to product requirements, design outputs, verification, and validation. Support the development of requirements and traceability for different disciplines such as Software, Electrical, Mechanical, and others.
• Develop and maintain test plans for System Integration, Verification and Validation working closely with the verification team. Oversee testing, analysis, and integration activities. 
• Create and manage Risk Management files, including Risk Management Plan, Risk Management Report, and Post-production Information Reports.
• 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. 
• Support process and best practices development and adoption and continuous improvement initiatives in accordance with regulations.
• Teach and mentor more 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 systems engineering experience. 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
• 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.