Senior Manager, Design Quality Assurance

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

Sibel Health Inc. is seeking a Senior Manager, Design Quality Assurance to perform the following duties:
Manage the development and implementation of a comprehensive software design quality strategy aligned with Sibel Health’s missions and goals, and regulatory requirements.
Provide governance for software design quality throughout the product development lifecycle, fostering a culture of quality, continuous improvement, and compliance.
Manage and oversee all aspects of design quality assurance activities, including design verification and validation, and risk management, in compliance with applicable regulatory standards such as ISO 13485, IEC 62304, and FDA 21 CFR Part 820.
Ensure robust design control processes are in place, including design reviews, design history files (DHF), and design transfer activities.
Guide cross-functional teams, including R&D, manufacturing, regulatory affairs, clinical, and product management, to ensure seamless integration of quality assurance processes for software development projects.
Develop and maintain quality metrics, key performance indicators (KPIs), and reporting systems to monitor and enhance product quality and reliability.
Ensure compliance with global regulatory requirements and standards for software development and design controls, as established by agencies, including but not limited to the FDA, EU Commission, TGA, Health Canada, and other relevant regulatory bodies.
Lead internal and external audits, inspections, and assessments, addressing any findings or non-conformances promptly and effectively.
Implement robust corrective and preventive action (CAPA) processes to address product quality issues and drive continuous improvement.

Requirements

• This position requires a Master’s degree in Bioengineering, Biomedical Engineering, or a directly related field and 3 years of experience as Software Quality Assurance Engineer, Software Quality Assurance Analyst, or closely related in Medical Device Industry in managing design control processes for medical device and Software as a Medical Device (SaMD) in accordance with ISO 13485, IEC 62304, and FDA 21 CFR Part 820, Or, a Bachelor’s degree in Bioengineering, Biomedical Engineering, or a directly related field and 5 years of experience as Software Quality Assurance Engineer, Software Quality Assurance Analyst or closely related in Medical Device Industry in managing design control processes for medical device and Software as a Medical Device (SaMD) in accordance with ISO 13485, IEC 62304, and FDA 21 CFR Part 820.

Salary & Benefits

• $121,389/yr -$150,000/yr
• Medical, dental, life, and disability insurance
• Paid Time Off
• Retirement Plan
• 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.