Director of V&V

Engineering – Hardware             ·             Chicago, IL             ·            Full time

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 of V&V to join our team. In this role, you will ensure multi-disciplinary engineering requirements, design outputs, verification and validation testing, and documented evidence meet all medical device quality management system regulations and standards relative to design control for the design development, and manufacturing of hardware, firmware, software and mechanical systems. You will work with hardware, application, and other cross-functional teams to react quickly and produce quality solutions to difficult technical challenges. 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:

• Develop test method plans, verification/validation plans/protocols, requirement traceability matrices, and summary reports in collaboration with cross-functional team members.
• Document and design verification and validation protocols and reports utilizing thorough knowledge of statistics, sample size determination, documenting sample size justifications/rationale and statistical data analysis of results.
• Lead a team of Test and Quality engineers for continuous updates and maintenance to documentation and execution of V&V protocols.
• Perform as Design Control subject matter expert and produce design documentation deliverables.
• Thorough knowledge and understanding of EN ISO 14971 and other risk management practices such as System Hazard analysis and Failure Mode Effects Analysis and constantly using these practices to integrate throughout the design and development process using best documentation practices.
• Expertise in Quality Management System regulations and standards including ISO 13485 and 21CFR 820 with a focus on 21 CFR 820.30 Design Controls and 21 CFR 820.70 Production and Process Controls.
• Established working knowledge of hardware, firmware, software and evaluation to standards, IEC 62304, 60601-1 and 60601-1-2.
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
• Experience with NCRs and CAPAs. Able to own and lead closure of a CAPA or NCR.
• Have an integral role in implementing software medical device lifecycle processes and work closely with the cross-functional team to support regulatory submissions and compliance activities.
• Support change control process through the creation of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance with procedures.
• Manage complex schedules that involve both internal and external engineering teams, as well as vendors, while prioritizing activities for rapid execution of critical path work items.

About You:

• BS in Engineering or related degree. Masters/PhD a plus.
• 5+ years of experience with medical device product design & development.

You May Thrive In This Role If:

• Solid engineering fundamentals in electrical, mechanical, software, systems, and/or other fields.
• Prior experience working on complex electromechanical medical devices, combination devices and/or connected medical products a plus.
• Experience working with third party suppliers of equipment and measurement systems.
• Good documentation practices and strong communication skills.
• Solid hands-on experience in analog and digital electronic circuit testing, prototyping, board bring-up and troubleshooting.
• Solid hands-on experience in design, installation and qualification of electrical and mechanical systems, test fixtures and rigs.
• Experience prototyping systems with various sensors for biomedical applications.
• Track record of creating design history file documents.
• Attention to detail, strong organization skills, and ability to work independently and in teams.

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.

Please click here to apply.