Senior Program Director at CESO managing client portfolios across various sectors and ensuring project delivery excellence while mentoring a team.
About the role
- Program Manager leading cross-functional teams in software quality system improvements for Abbott's Heart Failure division. Focusing on the design and development quality system with software integration.
Responsibilities
- Lead cross-functional teams to meet program objectives including scope, budget, and schedule
- Prepare and/or support detailed Quality Improvement Plans and other business plans
- Establish and prioritize project deliverables
- Author and review quality system procedures and work instructions
- Lead cross-functional teams to develop project timelines consistent with business strategy and expectations
- Support audits and present completed and planned development process improvements, as appropriate
- Identify and support implementation of harmonized software development tools
- Drive program execution per milestone commitments
- Ensure appropriate impacts, risks, mitigations are developed and communicated in the face of requested or required program commitment changes
- Prioritize program workstreams, consistent with business strategy
- Facilitate strong collaboration among cross-functional core team members
- Communicate with all levels of the organization the objectives, status, risks, and needs for the program
- Identify potential roadblocks early and lead the team to develop and implement counter measures
- Interface with appropriate internal and external resources (regulatory agencies, customers, etc.) to ensure development programs meet regulatory and customer requirements
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
- Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors
Requirements
- Bachelor’s degree in engineering
- 10+ years of experience in Quality, Engineering and/or R&D within a medical device/biomedical, high technology, and/or any other regulated industry
- Experience in software product development and process improvement
- Experience in applying FDA guidance for multiple function devices and creating quality system(s)
- Experience collaborating with project stakeholders (client and internal), end-users, business partners, and technical team members for development of quality systems
- Strong verbal and written communication skills with ability to effectively communicate with multiple levels in the organization
- Previous experience working in a matrixed and geographically diverse business environment
Benefits
- Career development with an international company
- Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
- Excellent retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
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