A BIT ABOUT SIBEL HEALTH

THE OPPORTUNITY

WHAT YOU WILL BE WORKING ON

• Own program planning, execution, and delivery aligned with Sibel Health's business goals.
• Maintain essential program management elements including action items, schedules, risk analysis, resources/budget, and lessons learned to ensure on-time, on-budget, and in-scope program delivery.
• Lead team 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 and approvals, and documentation delivery.
• Support the team by removing roadblocks during execution.
• Facilitate Core Team communication and activities including meetings, collaborative discussions, input documentation, and stakeholder engagement.
• Proactively manage risks with team-prepared mitigation plans to prevent impacts on program parameters.
• Escalate issues to relevant stakeholders and lead necessary discussions for resolution.
• Support PMO in improving program management processes, systems, and tools.
• Willingness to travel internationally up to 10% as required.

ABOUT YOU

• Minimum 5 years experience in Program Management for New Product Development/Introduction with a Bachelors Degree in Computer Science, Engineering, or related field.
• At least 5 years in medical device product development or similarly regulated industries such as automotive or military.
• Comprehensive understanding of medical device phase gate artifacts, V&V protocols, risk management, and requirements management.
• Creativity in streamlining program artifacts while meeting regulatory requirements.
• Excellent leadership and communication skills to coordinate varied functional team members, prioritize focus, and keep programs on track.
• Demonstrated successful program leadership from start to finish with strong ownership and accountability.
• Deep knowledge of core hardware development functions such as electrical and mechanical design, PCBA and tooling, quality/APQP, verification and validation testing, product and business management, and phased product development processes.
• Highly developed program leadership skills including risk balancing, influencing diverse teams, guiding organizationally aligned decisions, and owning outcomes.
• Ability to balance high-level strategic and detailed tactical thinking.
• Possess managerial courage to manage risks and make challenging decisions aligned with strategic objectives.
• Independent, self-directed with strong self-awareness, trust, credibility, integrity, and accountability throughout teams and leadership.
• Familiarity with tools including G-suite, Jira, Slack, Smartsheet, and other program management software.
• Project Management Professional (PMP) certification highly preferred.
• Experience with JIRA in managing both software and hardware development work items highly preferred.

YOU MAY THRIVE IN THIS ROLE IF YOU HAVE

• Over 8 years of new product development/introduction program leadership experience in the medical device industry.
• Thorough understanding of core program management principles with adaptability.
• Experience leading programs internationally and managing external contract services.
• Certifications such as PMP, Certified Scrum Master, or PRINCE2.
• Exceptional interpersonal skills in negotiation, change management, goal setting, team planning and organizing, conflict resolution, resource balancing, and problem-solving.
• Successful track record in managing multiple programs from conception through commercialization in medical devices.
• Experience in systems engineering, concept engineering, hardware/software development, validation, and systems integration.
• Experience with FDA regulatory submissions (US) and/or CE mark regulatory submissions (EU).
• Experience with regulatory submissions involving clinical studies (510k clinicals or IDE/PMA clinicals).

BENEFITS

• Medical, dental, vision, life, and disability insurance coverage.
• Flexible "Take as much time as you need" policy.
• Simple IRA retirement plan with employer matching.
• Company-sponsored events and lunches.
• Professional development stipend.
• Opportunity to join a dedicated team revolutionizing wireless monitoring technology.