Senior Program Manager

About the Role

Key Responsibilities

• Manage development, validation and early commercialization of novel and technically complex IVD devices and assays
• Establish, implement and administer effective program management tools and processes to plan, monitor and control complex, interdisciplinary programs
• Manage 510(k) submission process for IVDs to FDA
• Recommend, implement, monitor, report and improve key program metrics including but not limited to scope, requirements, budget, resource consumption, and schedule
• Effectively communicate status of programs to executive team with program risks and mitigation factors
• Manage multiple projects and tasks simultaneously and effectively influence, negotiate, and communicate with internal and external business partners, contractors and vendors
• Directly and indirectly lead internal teams to achieve goals within stated timelines
• Maintain compliance with all company policies, quality systems, and procedures
• Perform other duties as assigned

Requirements

• Bachelor's Degree in a technical discipline with 5 years experience in Project and Program management or similar
• Advanced technical degree or MBA preferred
• PMP or PgMP certified or equivalent a plus
• Previous experience in the life science industry is preferred
• Demonstrated ability to create, maintain, and report program status utilizing industry standard tools
• Strong understanding of product design and process design concepts and best practices
• Has led projects from inception to launch
• Excellent leadership skills and experience leading high-performance teams required
• Comfortable with programs that cross technology boundaries of software, hardware, and IVD assay development

Nice to Have

• Advanced technical degree or MBA
• PMP or PgMP certification
• Previous experience in the life science industry

Qualifications

• Bachelor's Degree in a technical discipline
• 5 years of experience in Project and Program management
• PMP or PgMP certification (preferred)

Benefits & Perks

• Competitive salary
• Health, dental, and vision insurance
• Flexible paid time off
• Stock ownership and equity participation
• Participation in annual target bonus plan