Sr. Manager, Design Assurance in Orange, California at KaVo Kerr

Date Posted: 6/23/2019

Job Snapshot

Job Description

Job ID: KAV003629

About Us

KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community.  KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential.  KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.


Description

The Sr. Manager, Design Assurance will be responsible for leading projects and activities to ensure quality is designed-in to the new products and in the Lifecycle Management. He /She applies knowledge of “Good Engineering Practices,” design control principles and quality engineering techniques to development efforts as a member of one or more cross-functional development team(s). The ideal candidate also ensures products are developed in accordance with applicable industry standards, regulatory requirements, and customer requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Responsible for assuring projects meet customer expectations- Help establish user needs and intended uses that are necessary and appropriate.
  • Lead engineering staff and other personnel to ensure that design control requirements are met in an effective manner, including verification, validation, specification and procedure development, risk management, and design review.
  • Develop “good” requirements early in the product development process, ensure that products can be adequately manufactured and tested, while achieving product quality and reliability targets.
  • Evaluates test protocols and reports to ensure that testing is sufficient to meet requirements, regulations and quality objectives.
  • Participate in test method development and execution.
  • Participates in design and process capability assessment and design reviews.
  • Leads Risk Management through definition and implementation.
  • Review DHF for accuracy and completeness and provide guidance on FDA compliance and procedures.
  • Represents design quality assurance department to FDA, ISO and all other auditors.
  • Assists in the development and maintenance of QMS procedures, reviews and approves Engineering Change Orders(ECOs).
  • Maintains knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
  • Lead/assist on complex technical problems with in-depth root cause analysis and corrective actions.
  • Provide mentoring and guidance to subordinates and other employees
  • This role is based in Orange Ca, and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.

Job Requirements



Qualifications

EDUCATION/EXPERIENCE:
  • Bachelor’s degree in an Engineering discipline required. 
  • 8+ years of relevant Design Assurance experience required within Pharmaceutical or Medical Device industries, preferred.
  • Ability to travel up to 25% domestically or internationally.
PREFERRED SKILLS:
  • Strong working knowledge of Engineering principles and its application in solving complex technical problems.
  • Strong experience in product risk management to the requirements of ISO 14971
  • Independent thinker, strong leadership skills, ability to organize complex work, drive change and promote a culture of execution.
  • Working knowledge of Minitab and tools such as Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Industrial Statistical Methods and Lean Manufacturing.
  • 2+ years of experience managing a staff of engineers.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified 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. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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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.