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Danaher Corporation Project Coordinator IVDR in Sunnyvale, California

Project Coordinator, IVDR Program Management

Overview:

You will be responsible for the coordination, implementation, execution, and completion of the In Vitro Diagnostic Regulation (IVDR) program while ensuring consistency with company strategy, commitments and goals. Working closely with the Program Leader, you will lead the cross-functional core team to ensure Cepheid is prepared for and completes the processes and tasks necessary to adopt the new IVDR regulations to ensure our products are ready and remain on the market. You will also be responsible for defining, measuring and communicating the program’s progress to the Program Leader and the L1 Exec Management Team as well as to executives at the Danaher Platform level. You will have extensive experience in leading program management activities across geographies.

Responsibilities:

  • Present reports defining program progress, problems and solutions to leadership

  • Followup on project tasks, timelines, deliverables and resource requirements

  • Track project deliverables using appropriate tools

  • Constantly monitor and report on progress of the project to all stakeholders

  • Manage and lead globally dispersed teams through multiple communication levels and mediums throughout the organization as well as external collaborators

  • Run Core Team meetings

    Qualifications:

  • Bsc. degree is required or higher within Life Sciences, Molecular Biology, Chemistry, and/or a technical discipline

  • MBA or Strategic Management background will be given priority

  • 2+ years of experience as Project Coordinator/Project Manager or similar position

  • Experience in work with virtual and dispersed project teams

  • Strong written and verbal communication skills

  • Highly organized, quality conscious and self-driven

  • Ability to handle multiple tasks under tight deadlines

  • Fluency in English in both written and verbal communication

  • Proven experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003

  • Possesses a high level of critical and strategic thinking skills and be a detail-oriented team player

  • Proven experience in priority setting as well as adapt to changing priorities

  • Ability to function in a changing, high-impact position, with deadline and resource constraints

  • Preferred Qualifications:

  • PMP or PgMP certification is a highly preferred

  • Strong technical background, preferably in the in vitro diagnostics or medical device industry

  • Demonstrated effective written and oral communications skills

  • Understanding of assay product development lifecycle

    Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid

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