The Beckman Coulter Hematology, Urine Analysis and Life Sciences product portfolio is diverse and includes new concepts for hardware, software, and clinical decision applications. The Director Design Quality and Lifecycle Management is engaged early in product design and development phase through post market with the objective to provide high quality, reliable, and regulatory compliant products to support worldwide market release in meeting the needs of our clinical customers, our patients, and Beckman business growth objectives. This position reports to the Vice President, Quality and Regulatory Affairs.
Business Leadership Attributes:
- Lead and manage the Design Quality (Design Assurance) product functional group within the to realize the Development Quality mission of collaborating with product development, sustaining engineering and other functional groups to efficiently bring regulatory compliant new products to market that meet or exceed customer expectations.
- Business Unit Quality lead for the post-market quality, direct and in-direct to drive continuous improvement, best practice sharing and harmonization.
- Drive product functional 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)
1) Technical Leadership responsibilities include:
- Form and maintain open communication and close collaboration between the Development 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).
- Leadership for the transition to IVDR compliance with the business
- Contributor to the overall success of the product development schedule, achieve accomplishment of Development Quality function deliverables, and assure timely completion of project required activities.
- Ensure Beckman Coulter products are compliant to Beckman corporate requirements as well as to FDA QSR, ISO, and other global regulations.
- Contribute to and support organizational (Hematology, Urine Analysis and Life Sciences), functional group (QA), and departmental (Development Quality) 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 IVD products by implementing quality objectives, methods, and requirements to make quality a competitive advantage.
2) Director Quality, Design and Lifecycle Management functional group role responsibilities include:
- Acquire, develop, and retain top talent in the function by developing and maintain a technically excellent high performing team.
- Lead reagent, systems integration, hardware and software Development Quality
- Lead Post Market Quality functions to ensure field performance and feedback into design and operations.
- Drive global strategies within business unit and also with other business units 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.
- 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
- 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.
Participate in department budgetary planning and forecasting; identify and communicate group budgetary needs and constraints; and ensure group performance to budgetary plan.
Basic Qualifications (basic skills and experiences necessary to perform the job)
- BS in Biochemistry or in related technical field with minimum 14+ years of experience or Master’s degree in field with minimum 15+ years of experience or Doctoral degree in field with minimum 9+ years of experience.
- Minimum 5 years in a QA functional role with 5 years accumulated manager level experience in career background.
- Experience with medical device new product development/product realization
- Experience in a regulated industry and knowledge of product regulatory requirements/submissions.
- 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
- Demonstrated ability to coach, mentor, and develop people
- Keen critical thinking 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
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.
Find one job in US 