Job Description

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 :

At Sibel Health, we are on the lookout for an experienced and dynamic Staff Program Manager (PgM) who thrives in managing a diverse range of projects, varying in both size and complexity, across multiple commercial and engineering disciplines. Here you will have the opportunity to lead and manage multiple projects, ensuring they are completed on time and within budget. All of this will be accomplished while working in a stimulating environment where you can expand your skills, grow your career, and be part of a great team with the mission to deliver Better Health Data for All®.

WHAT YOU WILL BE WORKING ON :

• Own program planning, execution, and delivery, in support of Sibel Health’s business goals.
• Ensure all essential foundational elements of program management are created, maintained, and reported on, including action items, program schedule, risk analysis, resources/budget, and lessons learned, while concurrently managing other activities to ensure programs are delivered on time, on budget, and within scope.
• Lead the team in adherence to organizational tools, processes, and requirements throughout the development lifecycle, including program planning, risk reduction, lessons Learned, change management, program status reports/dashboards, phase reviews & approvals, and delivery of internal & external documentation requirements.
• Support the team in removing roadblocks during program execution.
• Facilitate day-to-day communication and activities of the Core Team, including leading team meetings, enabling collaborative discussions, and eliciting input from key functional areas; documenting action items, decisions, and overall progress; seeking input from or looping in Subject Matter Experts or stakeholders from outside the Core Team as needed.
• Manage risks proactively, preparing mitigation plans as a team to avoid conversion into issues and impact to program parameters.
• Escalate issues, barriers, or concerns as appropriate to relevant stakeholders or leadership, and facilitate discussions necessary to drive decisions and resolution activities.
• Support PMO (Program Management Office) in identifying, recommending, and executing improvements to existing, and/or development of new, program management processes, systems and tools.
• Up to 10% international travel required.

ABOUT YOU :

• 5+ years of experience in Program Management in New Product Development/Introduction, with a Bachelor's Degree in Computer Science, Engineering, or related field.
• 5+ years in medical device product development, or other highly regulated environment (Ex. Automotive, Military).
• Must have a thorough understanding of medical device phase gate artifacts; V&V protocol/report anatomy, all elements of risk management, and all elements requirements management.
• Must have demonstrated creativity in streamlining program artifacts while meeting regulations.
• Excellent leadership and communication skills. Able to coordinate team members across varied functional disciplines, keeping the team focused on priorities and the program on track.
• Demonstrated track record of successfully leading programs to completion. Ownership, accountability, and the ability to move from big picture to detailed view.
• Excellent knowledge of core functional areas for hardware development and leading teams in relevant areas, including electrical & mechanical design, PCBA & mold tool manufacturing, quality/APQP, verification & validation testing, Product management, business management, and experience with phased product development processes are essential to this role.
• Highly developed skill set in program leadership practice, including the ability to balance risk, effectively influence diverse teams, guide teams in decisions that align with organizational goals and culture, and ownership of responsibility for outcomes.
• Good balance of high-level strategic and detailed tactical thought processes.
• Possess managerial courage. Confident in managing risks and making difficult decisions that drive strategic organizational objectives.
• Independent, self-directed, and highly self-aware. Able to establish trust and credibility throughout teams and leadership with unwavering integrity and fierce accountability.
• Familiarity with G-suite, Jira, Slack, Smartsheet, and other program management tools.
• Project Management Professional (PMP) (Highly Preferred).

YOU MAY THRIVE IN THIS ROLE IF YOU HAVE:

• 8+ years of experience leading new product development/introduction programs in the medical device industry.
• Thorough understanding of core program management principles and how to apply or adapt them as needed.
• Experience leading programs and program deliverables with international teams and external contract services.
• PMP (Project Management Professional), Certified Scrum Master, PRINCE2 certification.
• Exceptional influencing and interpersonal skills. Experience negotiating, managing change, goal setting, planning and organizing teamwork, conflict resolution, resource constraint, and problem-solving with the ability to address difficult situations.
• Successfully managed multiple programs from conception through commercialization ideally in the medical device industry.
• Exposure to systems engineering, concept engineering, hardware and software development, validation and systems integration.
• Experience in FDA regulatory submission (US) and/or CE mark regulatory submissions (EU).
• Experience in regulatory submissions requiring clinical studies (510k clinicals and/or IDE/PMA clinicals).

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.

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