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Sr. Design Assurance Engineer (Medical Software) in Brea, California at Ormco

Date Posted: 1/13/2019

Job Snapshot

Job Description

Job ID: ORM001355

About Us

Since 1960, Ormco, one of the many successful companies owned by Danaher Corporation, has been developing, manufacturing, and marketing a broad line of orthodontic appliances and related products for sale in the U.S. and abroad. Ormco provides orthodontists with brackets, wires, adhesives, and ancillary supplies used through the course of treatment.

Ormco believes the direct contact of its sales force with orthodontists facilitates the identification and verification of market trends and new product opportunities. Ormco works closely with orthodontists to improve existing products and develop new products primarily through its Champion programs in which selected orthodontists assist Ormco in designing, developing and ultimately educating users on new product and technique innovations.


The Sr. Design Assurance Engineer will be responsible for leading complex projects and activities to assure quality is designed-in to the new product and in the Lifecycle Management.  With comprehensive knowledge of engineering and problem-solving principles, he/she will apply “good engineering practices” that will not only meet regulations and standards but exceed customer satisfaction. This role is based in Orange, CA and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas. 

  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
  • As a Product Development Core Team member, proactively influence designs to achieve product quality and reliability targets that meet or exceed customer expectations
  • Lead complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways.
  • Develops or participates in establishing requirements for all verification and validation (design and process) activities
  • Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes
  • Leads development of Risk Management documentation.
  • Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions.
  • Mentors junior Design Assurance Engineers as required.
  • Participates in audits and inspections of the company and our quality systems.

Job Requirements


  • Bachelor’s degree in an Engineering, Life Sciences, Quality Assurance or similar discipline.
  • Minimum of 5 years in an FDA regulated product design and development environment; medical device experience industry high preferred.
  • Experienced in a Software Quality Engineering role.
  • Solid understanding of design controls and risk management (ISO 13485, 21 CFR 820 and ISO 14971).
  • Proficient in Statistical analytics, Advanced SPC, Quality Analysis Tools and DOE.
  • CQE (Certified Quality Engineer) preferred.
  • Requires the ability to perform independently and as part of a team.
  • Must be able to influence & negotiate with people & resolve issues.
  • Ability to make rational, objective & appropriate decisions relating to Design Assurance
  • Ability to identify customer needs & issues & develop realistic solutions to meet needs & solve problems.
  • Ability to communicate decisions across a wide spectrum of the organization.
  • Ability to mentor junior colleagues.
  • Required good writing skills.

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:


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 industrial solutions. Our globally diverse team of 59,000 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 #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 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.