Director Design Quality in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 4/23/2018

Job Snapshot

Job Description

Job ID: BEC006925

About Us

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. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20yrs.



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.




Description

About the Role


Beckman Coulter is transforming its IVD product development to accelerate the NPD process while delivering products that meet global customer expectations and compliance in all regions.  This new role will require a leader who can elevate development of IVD reagents and instruments at design centers in 6 sites (US, EU and Asia).  We are seeking a dynamic individual with demonstrated effectiveness in leading a global organization and track record to develop leaders.  Experience in application of lean principles to product development in the medical device industry will enable the individual to lead the transformation.   With multiple instrument systems and numerous assays currently in development candidates will be able to impact the business.   




Responsibilities


Lead and manage the design assurance team for chemistry/immunoassays supporting the mission of collaborating with Product Development and other functional groups to efficiently bring regulatory compliant new products to market that meet or exceed customer expectations.


Lead global Design Quality functions, direct and in-direct to drive continuous improvement, best practice sharing and harmonization


Drive Design Quality reagent assay & instrument group excellence by strengthening people skills, efficient methods, and engagement to assure optimal execution of strategies, achievement of product plans and continuous improvement in methodologies and processes.




Position Responsibilities (job duties and functions)


Technical skills




  • Form and maintain open communication and close collaboration between the Design Quality functional group and partner/client groups in leadership and professional roles (e.g., product development, product management, program management, regulatory, manufacturing operations, and project Core Teams).

  • Quality leadership for reagents, systems, hardware, software and consumables.

  • Proficient in problem analysis with experience using issue analysis/problem solving tools (such as root-cause analysis, fishbone diagram, D.I.V.E. process).

  • Experience with new product development/product realization

  • Experience in a regulated industry and knowledge of product regulatory requirements/submissions and ensure our products meet Beckman corporate requirements as well as to FDA QSR, ISO, and other global regulations.

  • Contributor to the overall success of the product development schedule, achieve accomplishment Dev QA function deliverables, and assure timely completion of project required activities.

  • Contribute to and support organizational (Chem IA), functional group (QA), and departmental (Dev QA) strategies. Translate and flow down higher level strategy, portfolio and project objectives into tactical functional group and individual strategies and plans.

  • Lead the development and implementation of functional group strategies and methodologies to define, allocate/implement and demonstrate state-of-the-art Chem-IA reagent products by implementing quality objectives, methods, and requirements to make quality a competitive advantage.

  • Leadership skills include:

  • Acquire, develop, and retain top talent in Dev QA function by developing and maintain a technically excellent high performing team.

  • Lead Reagent, Systems Integration, Hardware and Software Development Quality teams

  • Able to manage global sites in US, EU and Asia 

  • Drive global strategies within the business unit and also with corporate quality to continue to enhance product realization processes in compliance.

  • Align the functional group around shared goals.  Optimize the group’s work.  Increase partner understanding of the group’s roles, responsibilities, and value propositions.

  • Establish functional group training requirements.  Identify and enable targeted training to improve functional skills and address individual developmental needs.  Provide active mentorship and functional support to ensure employee and project success.

  • Regularly assess and actively manage individual and group performance; engage in the creation and implementation of employee development plans.

  • Recognize and reward achievement, commitment and excellence in the advancement of organizational, departmental and group strategies.

  • Provide staffing, resource allocation and work direction to effectively and efficiently achieve portfolio, project/functional goals and objectives.

  • Establish and ensure timely execution of group and individual objectives to drive functional and strategic performance

  • Participate in department budgetary planning and forecasting; identify and communicate group budgetary needs and constraints; and ensure group performance to budgetary plan.


Job Requirements



Qualifications

Qualifications 




  • BS in Biochemistry or in related technical field with minimum 20+ years of experience or Master’s degree in field with minimum 18+ years of experience or Doctoral degree in field with minimum 9+ years of experience.

  • Minimum 5 years in a QA functional role with 6 years accumulated manager level experience in career background. 

  • Experience in people management roles such as a project team lead, Kaizen event leader, contract personnel management, or temporary functional group management responsibility.

  • Completion of basic manager training course (e.g. “Leadership Essentials” or similar such as Situational Leadership, Mosaic, or Kepner-Tregoe training).

  • Fluent in English language

  • Proficient in word processing, spreadsheets, MS PowerPoint, and project management tools




Desired/Preferred Qualifications (skills and experiences beyond Basic Qualifications)




  • Demonstrated ability of people management skills.

  • Well-developed written and oral skills

  • Work experience in all Quality disciplines (Material, Manufacturing, Design/Reliability, Post-Market Surveillance, Quality Systems, Configuration Assurance, and Quality Control).

  • Working knowledge of statistical techniques and quality/reliability tools (such as FMEA, FTA, DOE, SPC)

  • Proficient in data analysis with experience using issue analysis/problem solving tools (Root Cause Analysis, 8-D, etc.).

  • In addition to technical degree a Master’s in business administration, or similar

  • Experience with new product development and product realization

  • Experience in a regulated industry and knowledge of regulatory requirements/ submissions

  • Ability to support several projects simultaneously while effectively adapting to changing project parameters

  • Physical Job Requirements (physical requirements necessary to perform the job)

  • Mobility Requirements:  Stand/Sit/Walk 8 hrs/day; ability to travel across campus and between facilities.

  • Dexterity Requirements:  Able to use computer & monitor to develop, review and communicate job-related documentation.

  • Vision requirements:  Correctable to 20/20 in 1 eye and 20/40 in other eye.  Able to use computer & monitor to develop, review and communicate job-related documentation.

  • Hearing requirements:  Able to participate in meetings and conference calls and to use a telephone.

  • Travel, as needed, approx. 20%




Beckman Coulter Diagnostics is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities. As a Beckman Coulter Diagnostics employee you will be consistently challenged to deliver your best.




If you are ready for this challenge, apply on-line and submit your resume for consideration.




Beckman Coulter Diagnostics is an Affirmative Action and Equal Opportunity Employer: Race, Color, National Origin, Religion, Sex, Disability, Vet, Sexual Orientation, and Gender Identity.




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Danaher Corporation Overview

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, 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. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 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.




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.