Position Details

MEDICAL DEVICE PROJECT MANAGER

Medical Device Project Managers
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

Summary:
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.

Responsibilities:
• 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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