Job Description

The Senior Commercial Program Manager will be responsible for managing large-scale, highly complex, multi-faceted new product development programs, strategic initiatives or integrations involving internal and external development partners. All projects and programs will involve leading multi-functional & global core teams with both internal and external team members. Responsibilities include the planning of all program components and project deliverables. This includes the synchronization and prioritization of Core Team activities. Scope includes management of the overall program schedule, resource requirements, risk assessment and project investment analysis and budget. The Senior Commercial Program Manager is responsible for directly and indirectly driving program execution in the regions and all development efforts (internal and external) while ensuring that all program deliverables and efforts are connected and meet internal and external customer requirements and follow OSTA’s (Olympus Surgical Technologies of America) Product Development Process (PDP), including progress reporting and reviews by senior leadership.

The ideal candidate has strong organizational skills, strategically minded and self-motivated with excellent analytic, facilitation and communication skills (both oral and written).

Job Duties

• Plan and execute highly complex large scale internal and external development efforts involving both application and embedded software development.
• Participate & facilitate in the early-stage process of gathering customer input and outlining the user requirements for the project.
• Coordinate the alignment of all project functional areas along with R&D counterparts to ensure all necessary goals, activities, and KPIs across relevant functions are included in project plans.
• Ensure that appropriate participation and involvement by appropriate stakeholders and key decisionmakers are included in all project plans and execution workstreams.
• Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively propose solutions.
• Provide regular project updates (written and verbal) to appropriate management board, R&D leaders, business stakeholders and extended team members as well as partners.
• Daily program responsibilities include:
  • Ensure team accountability and milestone achievements, and effectively manage performance issues and conflicts.
  • Implement and manage project changes and interventions to achieve timely project outputs.
  • Provide input to functional directors/managers on team member performance.
  • Project planning and management responsibilities for all assigned projects. Including development of a project charter, objectives, project plan and schedule.
  • Develop and manage budgets for the project including resource loading, external expenses and capital requirements.
  • Continuous prioritization of team member activities and follow up on actions.
  • Develop a team culture of continuous improvement and teamwork that strives to improve in quality, safety, delivery, and cost.
  • Actively seek collaboration and build relationships with internal customers and external partners to improve overall outcomes and timely project execution.
• Other Essential Duties as directed.

Job Qualifications

Required:

• BS Degree in Engineering, Computer Science or Technical Field required.
• Minimum of 5+ years of experience in the medical device field required.
• Minimum of 6+ years of successful demonstrated experience in managing large, technically complex new product development projects involving software or software components required.
• Understanding of Agile software development methodologies required.
• Other Considerations;
  • Travel a minimum of 25 % (including international)
  • Occasional evening and weekend work from home required.
  • Other projects and duties as necessary and assigned.

Preferred:

• PMP and PMI-ACP certifications with 3+ years in leading software projects preferred.
• Lean Six Sigma black or green belt certification preferred.
• Highly effective at dealing with change and ambiguity as business needs shift, responding well under pressure and demonstrating flexibility while ensuring compliance.
• Expert level Microsoft Project, Microsoft Excel, PowerPoint.
• Experience managing software development projects.
• Understanding of relevant medical device standards (IEC 60601-1 and IEC 62304).
• Experience in developing products to meet FDA guidelines for cybersecurity preferred.