Philips Program Manager Field Action Team in Highland Heights, Ohio
We welcome you to join Philips as a Sr. Program Manager in our Cleveland, Ohio location
As a Sr. Program Manager for the Field Action Team you will be responsible for ensuring that processes for specifying and executing field actions are adequate to ensure the expectations of all key stakeholders are met. Monitors and coordinates the different sub-system feeders to this process such as complaint handling, engineering change orders, kit suppliers, regulatory submission and field deployment. Prepares key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports. Ensures alignment between risk assessment and management.
Your key responsibilities
Planning, leading, organizing, and motivating project teams to achieve a high level of performance and quality in delivering projects with a strong focus on satisfying the customer needs.
Manage several concurrent high visibility projects in a fast-paced environment that may cross multiple business divisions.
Lead a cross-functional team to assess the need for a new project based on the voice of our customer and internal data, and lead the team to document and defend the decision.
Architect high-level project plan complete with key integration points and marry this with bottoms-up planning to design an aggressive, yet realistic project planned optimized to reach business objectives.
Assist project team members to create detailed work breakdown structure and realistic estimates that will both help the team to estimate the project and have a solid mechanism for tracking progress.
Drive overall project execution to achieve schedule and content within budget.
Ensure clear quality goals are created and communicated that ensures the team has clear targets to enable top quality delivery the first time.
Align functional team activities (engineering, service, purchasing, marketing, manufacturing, finance, regulatory etc.), often with global reach across sites, through a structured approach to assure effective project delivery.
Use a high level of knowledge and experience in blending Traditional and Agile project management principles in the right proportions to fit large, complex, mission-critical, enterprise-level projects and provide the right balance of agility and predictability.
Establish a measurement and reporting framework to review progress with key stakeholders.
Develop key performance indicators (KPI’s) to measure progress.
Recommend course corrections to the project plan as required, drive decisions to closure with project team and all stakeholders, and build the results into updated plans
Use appropriate project management tools, communication plans and risk management techniques to create rigor in project planning and execution.
Ensures that processes for specifying and executing complex field actions are adequate to ensure the expectations of all key stakeholders are met
Leads cross functional team to release on time, high quality and compliant field actions of high complexity
Manages recall responses, recall file documentation and recall file completion
Prepares key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports
Continuously track field actions and provide ongoing information to FCO team as required
Ensures alignment between risk assessment and management documentations and documentation for field actions
Manages recall responses, recall file documentation, recall file completion
Provides relevant feedback and insights from customers/filed to development/engineering teams to ensure learnings from previous projects are captured, synthesized and made available for next project teams
Continuously tracks field actions and provide ongoing information to Regulatory Operations as required
Master’s degree or equivalent work experience
5+ years’ experience in a medical device and/or other regulated industry (Pharma, IVD).
5+ years of working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR.
• Supervisory and or other leadership experience is preferred.
• Project management experience is preferred.
We are looking for
· 3 or more years project management experience leading cross-functional product development projects.
· Strong written and verbal communication skills required.
· Experience working in more than one functional area (operations, engineering, purchasing, quality, sales, etc.), with deep understanding of R&D product development preferred.
· Experience leading projects that span multiple countries preferred.
· Ability to lead by influence required.
· Strong problem-solving skills required.
· Understanding of financial analysis tools preferred.
· Computer-literate with working knowledge of Microsoft Project, Microsoft Excel, Pow erPoint, and Word required.
· Six-sigma knowledge & Certification preferred.
· PMP Certification preferred.
· SCM Certification preferred.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.