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Danaher Corporation Validation Engineer in Carlsbad, California

Danaher Company Description
At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.

On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.

Want to know more about our mission and vision? Click on the link:Link of YouTube video __ Our people At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.

Description
SenDx Medical Inc. is seeking an experienced Validation Engineer to lead validation activities by initiating, developing, and helping to implement validation projects to ensure the company’s processes are capable of consistently meeting their intended specifications and requirements. This includes studying existing and new processes to help identify and implement necessary validations.

This position works within the RA/QA Department, and cross-functionally with several other departments as a technical resource on project teams to ensure that documentation exists in support of product and process changes within the quality system.

  • Ensure all processes are in a validated state of control. Perform prospective, retrospective, and revalidations as needed.
  • Generate FMEA documents, validation test protocols, validation reports, other required documents, and perform statistical analysis to support validation activities. Train staff on changes to documents as needed.
  • Track validation packages to completion, establish schedule for review and potential revalidation. Review completed validation packages for compliance with quality system and relevant validation requirements. Transfer completed validations into production.
  • Manage the validation project board by leading reoccurring cross-function meetings to achieve objectives within required time frames. Utilize lean principles to set and meet continuous improvement goals.
  • Perform investigations associated with validation activities
  • Generate and maintain the Master Validation Plan and lead validation activities by initiating, developing, and helping to implement validation projects
  • Develop and manage multiple validations with a focus on establishing robust process validations while achieving timeline objectives.
  • Design experiments and interpret experimental data utilizing JMP software to generate informed analytical decisions to support validation activities.
  • Observe and analyze operational processes to identify validation needs.
  • Work with the research and development teams as assigned on new products, implementing design for manufacturability. May assist in Design Control activities.

Radiometer 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.

Qualification
* Minimum 5-8 years experience in regulated industry * Experience in QSR, ISO 13485, ISO 14971 and IVD preferred * Practical knowledge of risk management processes, statistical data analysis, and change control preferred * Significant Process and Design Validation experience preferred * Test Method Validation experience preferred * Significant Process and Design Validation experience

Education Bachelor’s degree in Engineering or Life Sciences or related field

Travel Domestic and International travel 10%

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 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.

Organization: Radiometer
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Carlsbad
Schedule: Full-time
Req ID: AME000195

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