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 looking for a Director, Engineering Verification and Release Management to join our team who will be responsible for ensuring all functions of Design Assurance & Engineering Releases comply to all applicable internal, domestic and international quality regulations as well as to user needs and internal system/product requirements. You will work with Systems, Engineering, Manufacturing, Program Managers, and other cross-functional teams to react quickly and manage engineering verification, quality assurance and release management function. This position is granted the authority to take any actions required to fulfill the scope, duties, and responsibilities of this position in direct support of medical device development, compliance, release and launch. Sibel’s fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative design, strong communication skills, teamwork, and more. 

WHAT YOU WILL BE WORKING ON:

• Lead and develop global Engineering test organization to perform unit, system and system verification of medical devices to ensure quality of releases to Sibel’s customers and patients.
• Establish test metrics within organization to support early containment of defects and thoroughness in verification efforts.
• Strategize execution aspects of Verification to optimize for cost while improving effective of verification cycles during product development process.
• Contribute to efficiencies in engineering processes.
• Lead release readiness review during phases of design and development and approve/reject checkpoints from quality of releases perspective.
• Manage business relationship of contract vendors.
• Champion quality improvement initiatives. Identify the opportunities for continuous improvement of the Quality Systems, including Product Development Process and document generation.
• Enforce design controls and support the definition and execution of R&D driven design transfer activities.
• Partner closely with Engineering implementation teams, Program Management, Product Management. 

ABOUT YOU:

• B.S. in Engineering discipline, Masters preferred.
• 10+ years’ experience in managing test organizations, preparing test strategies, with a history of product launches and supporting launched products, preferably in medical device industry.
• Ability to travel internationally as needed.
• Successful track record of driving and managing change in a dynamic environment and achieving results by setting high standards and holding people accountable for performance. 
• Proven experience leading and coaching to improve individual and team performance. 
• Proficient in rigor needed to lead testing and release readiness.
• Metrics driven to improve test coverage, defect containment and speed of releases.
• Capability to work in a fast-paced, dynamic global environment with multiple changing priorities. 

YOU MAY THRIVE IN THIS ROLE IF YOU:

• Have supported development to commercialization of medical devices per FDA 21 CFR Part 820, ISO 14971 and ISO 13485 regulations.
• Establish a vision and direct others with clarity in midst of ambiguity.
• Have the ability to lead by example and exert influence. 
• Seek solutions as you observe problems and gaps.

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.
• Capability to work in a fast-paced, dynamic global environment with multiple changing priorities.

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.