Program Manager at DaVita developing and executing leadership initiatives across the organization. Collaborating with various teams to enhance teammate skills and performance with a focus on AI integration.
About the role
- Program Manager responsible for leading cross-functional teams in quality assurance for Abbott's Heart Failure division. Ensuring project timelines, deliverables, and compliance within medical device development.
Responsibilities
- Lead cross-functional teams to meet program objectives including scope, budget, and schedule.
- Core responsibilities include.
- 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 (project timeline)
- 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 (regulated and not regulated as a medical device) and creating quality system(s) and associated infrastructure to support.
- 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 where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
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