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Project Manager

Company: Danaher
Location: Vista
Posted on: June 13, 2021

Job Description:

At Leica Biosystems our promise is to enable clinicians to efficiently provide patients a highly confident diagnosis within 24 hours of biopsy. We offer the most comprehensive portfolio that spans the entire cancer diagnosis workflow from biopsy to diagnosis. Our experts are committed to delivering Improved Quality, Integrated Solutions, and Optimized Efficiencies leading to breakthrough advances in diagnostic confidence and turnaround time.

In partnership with the Director, Program Management, you will be responsible for planning and managing the road map and provide guidance for projects to successfully drive the business forward through agreed upon scope, cost, schedule, and quality objectives.

Responsibilities we will trust you with:

  • Manage and drive cross-functional programs from end-to-end, covering a range of areas including HW/SW, applications, platform, SaaS, and Imaging
  • Lead SCRUM development process - support Systems Development and Application Development managers on sprint planning, daily stand-ups, reviews and retrospectives
  • Responsible for project budget estimation, resource planning and monitoring and managing project within budget
  • Actively manage program risks and associated issues to minimize impact to the success of the program
  • Liaise with product manager on project requirements and deliverables and regulatory teams on regulatory requirements and deliverables.
  • Engage with manufacturing and procurement groups as part of core team to ensure timely manufacturing transfer of developed product.
  • Coordinate product sustainment development projects in association with technical services team
  • Presentation of project plans, development updates and deliverables to Product Planning Group (PPG) team, project stakeholders and business associates.
  • Responsible for clear and concise reporting and escalation to project sponsor of project progress, risks, countermeasures and issues
  • Maintain visual management of project progress (master schedule and core team deliverables)
  • Maintain project documentation to standards required by Leica quality management system (QMS)

Qualifications/Requirements

  • Experience in product development of medical devices involving HW, SW, Test and Integration preferably with RUO/Clinical applications is required
  • Track record in managing projects with regulatory requirements and 510K process - knowledge of ISO13485 / ISO9001
  • Ability to pro-actively identify project roadblocks and implement countermeasures on time to prevent project delays
  • Experience in managing cross functional teams as Core Team Leader

Desired Skills/Experience

  • Minimum of 5 years of experience in Technical R&D program management of medical devices, preferably on Class II or higher medical devices
  • Working knowledge of design controls, regulatory requirements (US, EU, Japan, China etc)
  • Working knowledge of Software project development using SCRUM/SPRINT process
  • Experience in launching at least two products using Toll Gate process from concept
  • Professional qualification in project management (e.g. PMP Certification preferred)
  • Experience in deploying PMO processes, tools and templates

Education

  • BS Degree Computer Science, Mechanical Engineering or Electrical Engineering or STEM related fields
  • Master's Degree preferred

Travel

  • Occasional trips of about 10% to Leica business sites, customer sites and conferences, depending on business needs

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.

Keywords: Danaher, Vista , Project Manager, Other , Vista, California

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