Program Manager in Vista, California at Leica Biosystems

Date Posted: 9/13/2018

Job Snapshot

Job Description

Job ID: PAT000498

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.

Leica Biosystems Imaging, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. 

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Description

Leica Biosystems Pathology Imaging designs and develops medical imaging and analysis systems. This group operates within Leica Biosystems Pathology Imaging, a dedicated strategic business unit of Danaher Corporation for the delivery of world leading solutions in healthcare and research for ePathology, Cytogenetics and Clinical Microscopy. The Program Manager is responsible for managing research and development projects in Vista, California for new ePathology products and sustainment of existing product lines.

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.

Major Responsibilities 

•Project Execution:
Drive project planning, daily management, project execution and on-time delivery of products
Manage and drive cross-functional programs from end-to-end, covering a range of areas including HW/SW, applications, platform, SaaS, and Imaging
Daily management of project core team activities
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 and managing project within budget
Responsible for project risk management 
Liaise with product manager on project requirements and deliverables 
Liaise with regulatory team and product manager on regulatory requirements and deliverables.
Support Systems Development and Application Development managers with integration of off-shore resourcing into development projects
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

•Progress Reporting:
Presentation of project plans, development updates and deliverables to Product Planning Group (PPG) team, project stakeholders and business associates.
Frequent reporting to and interaction with executive level company management and functional leaders 
Maintain visual management of project progress (master schedule and core team deliverables)

•Process Compliance/Improvements:
Maintain project documentation to standards required by Leica quality management system (QMS)
oSupport QMS and regulatory audits as needed
oDevelop an understanding of Danaher Business System tools and processes and utilize in daily work

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate 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.

Job Requirements



Qualifications

Required Skills/Experience 
•Experience in development of medical devices involving HW, SW, Test and Integration preferably with RUO/Clinical applications is required 
•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
•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. PMI) 
•Experience in deploying PMO processes , tools and templates 
•Pathology imaging systems
•Prior experience with Danaher Business System (DBS)

Education 
•BS Degree Computer Science, Mechanical Engineering or Electrical Engineering or related fields.
•Master’s Degree preferred

Language 
•English

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

Competencies/Behaviors 
•Excellent communication skills
•Excellent presentation skills
•Problem solver – resourceful, flexible, out-of-the-box thinking
•Motivator – enthusiastic and positive attitude
•Self-starter, autonomous leader, able to work with minimal supervision

Key Relationships
•Internal
Reporting to Head of PMO, Leica Biosystems Pathology Imaging Business Unit
Working closely with various functional groups
Liaising with level one management team, PPG, product managers and associates in R&D, manufacturing, regulatory/Qualiy, service, sales and marketing

•External
N/A



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.