## Danaher Company Description
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. Hospital laboratories are our core clinical diagnostic customers. Our life science customers include pharmaceutical and biotechnology companies, universities, medical schools and research institutions. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 years, our products have been making a difference in peoples- lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
## Description
The Beckman Immunoassay product portfolio is diverse and includes new concepts for hardware, software, and immunoassay clinical decision applications. This position will be engaged from the early product design software development phase through market release with an objective to provide quality, highly reliable, and regulatory compliant products to support worldwide market release of product that meets the needs of our clinical lab customers, our patients, and Beckman business growth objectives.
This position will join a Core Team tasked with a mission to develop and manufacture Immunoassay Diagnostic instrument products in China and will report to the Chaska Senior Manager for R&D; QA. Travel expectations to Beckman-China and potential Asian based supplier sites may be 15-20% at peek points in the project.
**_Business Leadership Attributes: _**
* Fulfill the Development QA role on Instrument Hardware Product Development Core Team as the design progresses through development. Understand the product design/process reliability and ensure the creation of documented evidence of compliance to Beckman Quality System and applicable regional regulatory requirements.
* Collaborate effectively on a Core Team in defining performance requirements, conducting risk analysis, and verification test plan execution. Drive to achieve Design for Reliability and Manufacturing results by effective use of applicable Danaher Business System tools.
**_Position Responsibilities (_job duties and functions_)_**
1) Technical Leadership responsibilities include:
* Provide QA support to Beckman Immunoassay product development projects in the areas of Quality Systems, Quality Assurance, Reliability, Configuration Assurance, and Risk Management.
* Work with minimal direction and consult with or delegating to, identified quality function specialist within the organization.
* Contribute to achievement of the project schedule and timely completion of the R&D; QA function deliverables to the project.
* Ensure that assigned tasks are compliant to Beckman applicable procedural requirements as well as to FDA QSR, ISO, and applicable global regulations.
2) R&D; QA Functional Role Responsibilities include:
* _Design Control_: Complete specifically assigned task related to completion of Design Input documents, Verification & Validation data review, Risk Management, Design Transfer, and other associated QA function deliverables.
* _Quality Assurance_: Effective interaction with members of the R&D; QA function to ensure that product Design History File documentation is organized, complete per applicable procedure, and compliant to the FDA and international regulations.
* _Process and Procedure Improvement_: Complete assigned task related to supporting R&D; QA process and procedure improvement initiatives.
Beckman Coulter 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.
## Qualifications
**_Basic Qualifications _(basic skills and experiences necessary to perform the job)__**
* BS in Mechanical/Electrical Engineering or in related technical field with minimum 9+ years of experience or Master’s degree in field with minimum 7+ years of experience or Doctoral degree in field with minimum 4+ years of experience.
* 2 years of experience in QA role within an Instrumentation (Hardware/Electrical) product design and manufacturing environment.
* 2 years of experience on cross-functional team and/or managing projects involving multiple tasks.
* Demonstrated knowledge of instrumentation system risk assessment, modular design concepts, instrument verification testing, and system/sub-system requirements development and traceability.
* Experience in the establishment of Product Design Development and MFG. process of medical instrumentation or devices to an Asian country.
* Working knowledge of IEC 60601 Electrical Safety standard its application and compliance requirements
* Fluent English language
* Proficient in word processing, electronic documentation systems, spreadsheets, and project management tools
**_Desired/Preferred Qualifications _(skills and experiences beyond Basic Qualifications)__**
* Demonstrated ability of influence and persuasive management skills.
* Well-developed written and oral skills (work examples recommended).
* Practical experience in other Quality disciplines (Supplier, Manufacturing, Design, Post-market Surveillance, Quality Systems, and Quality Control).
* Ability to write in Chinese and speak Mandarin language
* ASQ certification as a Quality or Reliability Engineer
* Working knowledge of statistical techniques and quality/reliability tools (FMEA, FTA, Affinity Diagrams, etc..)
* Experience with new product development and product realization processes
* Experience in a regulated industry and knowledge of product regulatory submission requirements
Ability to support several projects simultaneously while effectively adapting to changing project parameters
## Danaher Corporation Overview
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries. Our team of 66,000 associates around the globe is united by the Danaher Business System which serves as our ultimate competitive advantage. In 2013, we generated $19.1 billion in revenue, earning a spot on the Fortune 200 list. During the past 20 years, our stock has outperformed the S&P; 500 Index by nearly 2,800 percent.
*Organization:* Beckman Coulter
*Job Function:* Quality
*Primary Location:* North America-United States-MN-Chaska
*Schedule:* Full-time
*Req ID:* DIA003884