Manufacturing Engineer in Vista, California at Leica Biosystems

Date Posted: 11/18/2019

Job Snapshot

Job Description

Job ID: PAT000582

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

Under the direction of the Sr. Manager of Manufacturing and Operations, the Manufacturing Engineer will work cross functionally to develop, test and implement new and improved manufacturing and test processes and equipment necessary for the manufacture of an evolving product line of digital scanners.

This position will be expected to manage all aspects of assigned projects from inception to production implementation, including implementation of continuous improvement ideas into all aspects of the Manufacturing operation.

Major Responsibilities:
  • Design and development of manufacturing processes for new products, product changes, component obsolescence and enhancements, as well as related tooling and fixtures.
  • Lead all Process and Equipment Validation activities as required.
  • Work closely with Manufacturing Department Personnel to cultivate process improvement ideas.
  • Provide “Design for Manufacturing” expertise and ensure smooth design transfer to production for new product and process development projects.
  • Provide training and troubleshooting support to Manufacturing personnel
  • Partner with Quality organization to ensure Manufacturing compliance and audit readiness for GMP, ISO, Federal and other Regulatory entity standards.
  • Update and maintain Master Validation Plan (MVP)
  • Manufacturing/Operations representative on Material Review Board (MRB)
  • Create and maintain oversight and validation requirements for UDI-USB barcode numbering, associated printers and related labeling system
  • Partner with Supply Chain on Cost Reduction Initiatives

Job Requirements



Qualifications

  • Bachelor’s degree in a related engineering discipline such as, Industrial, Manufacturing, Mechanical, Biotechnology
  • Minimum of 3 years' experience in an Engineering Role.
  • Experience writing manufacturing and test procedures.
  • Expertise leading process validation activities, writing validation protocols and reports.
  • Proven knowledge of Lean Manufacturing techniques and principles.
  • Computer skills including Word, Excel, Statistical Software, Solid Works.
Desired Education, Experience, Skills
  • Familiarity with motion control, optical systems and digital imaging.
  • Knowledge and experience with GMP, ISO and FDA Regulatory standards
  • Strong Project Management skills
Language Requirements
  • English
  • Other languages considered an asset
Travel Required
  • Occasional domestic and international travel possible

Physical Demands & Working Environment:
The physical demands and work environment characteristics described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.(This includes office environment to a warehouse with cement floors, to an outdoor environment. Include any unusual conditions, such as hazards, loud noise, and extreme temperatures)
  • Physical demands: While performing the duties of this job, the employee is occasionally required to walk, sit, stand, use hand to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance, stoop, bend, talk and hear. The associate may occasionally lift and/or move up to 25 lbs. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
  • Work environment: While performing the duties of this job, most work is in an office and assembly production environment, with limited exposure to electrical hazards, cement floors, operating forklifts and moving mechanical parts. Lighting and temperature are adequate. The noise level in the work environment is usually quiet to moderate.
  • May be requested to work extended hours and weekends for special program events


Diversity & Inclusion
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.


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, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.