Position Details


Medical Device Project Managers (2 positions, 1 more hardware, 1 more software)
Direct Hire
Salary is DOE; Target is ~125-140k + 10% bonus
Vista, CA 92081

Required Skills/Experience:
• Experience in development of medical devices involving HW, SW, Test and Integration preferably with RUO/Clinical applications
• Ability to grasp key technical issues/challenges and steer the team to resolution working closely with engineers and functional leads
• Track record in managing projects with regulatory requirements and 510K process – knowledge of ISO13485 / ISO9001 and FDA
• 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
• BS Degree Computer Science, Mechanical Engineering or Electrical Engineering or related fields
• Must be comfortable working in a globally distributed team and the constraints/demands of different time zones; 10% travel

Desired Skills/Experience:
• Working knowledge of Software project development using SCRUM/SPRINT process
• Heavy 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.)
• Experience in launching products using Toll Gate process from concept
• Professional qualification in project management (e.g. PMI)
• Experience in deploying PMO processes, tools and templates
• Pathology imaging systems
• Prior experience with Danaher Business System (DBS)
• Master’s Degree

Soft Skills: • Outstanding analytical, critical thinking and problem solving skills
• Excellent written and verbal communication skills

The primary role is to lead a cross functional team of primarily R&D, product management, RA/QA and Operations, taking responsibility for planning, daily management and execution, on time delivery and product launch of strategic projects in accordance with master plan approved by the Product Planning Group.

• Project Execution:
o Drive project planning, daily management, project execution and on-time delivery of products
o Manage and drive cross-functional programs from end-to-end, covering a range of areas including HW/SW, applications, platform, SaaS, and Imaging
o Daily management of project core team activities
o Lead SCRUM development process – support Systems Development and Application Development managers on sprint planning, daily stand-ups, reviews and retrospectives
o Responsible for project budget estimation and managing project within budget
o Responsible for project risk management
o Liaise with product manager on project requirements and deliverables
o Liaise with regulatory team and product manager on regulatory requirements and deliverables.
o Support Systems Development and Application Development managers with integration of off-shore resourcing into development projects
o Engage with manufacturing and procurement groups as part of core team to ensure timely manufacturing transfer of developed product.
o Coordinate product sustainment development projects in association with technical services team
• Progress Reporting:
o Presentation of project plans, development updates and deliverables to Product Planning Group (PPG) team, project stakeholders and business associates.
o Frequent reporting to and interaction with executive level company management and functional leaders
o Maintain visual management of project progress (master schedule and core team deliverables)
• Process Compliance/Improvements:
o Maintain project documentation to standards required by Leica quality management system (QMS)
o Support QMS and regulatory audits as needed
o Develop an understanding of Danaher Business System tools and processes and utilize in daily work

Company / Benefits:
• Company makes Cancer Diagnostics Equipment and Software
• Excellent Medical, Dental, Vision, FSA, etc.
• 401k and Retirement Plans
• Holidays – Eight fixed holidays and 2 floating holidays each year
• Paid Time Off – 3 weeks/year; accruals increase by 1 week at 5 years
• Commuter Benefit
• Life, Disability, Pet, and other optional Insurances
• Employee Legal, and Adoption Assistance Programs

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