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Program Manager
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Summary
P rogram Manager
Hybrid/ Chicago IL
12 Months and Possibility to Hire
Hybrid/ Chicago IL
12 Months and Possibility to Hire
- 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 improvements to existing, and/or development of new, program management processes, systems and tools.
- Up to 10% international travel required.
- 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).
- 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).
- 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).