Design Assurance Engineer

Industry: Engineering

Location: CA

Job#: 105512


Description

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 product life-cycle.  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 Brea, CA and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Actively participates in defining customer requirement, product claims and target markets early in the product development life-cycle.
  • 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.

REQUIREMENTS:

  • Bachelor’s degree in an Engineering, or similar discipline.
  • Minimum of 5 years in an FDA regulated product design and development environment; medical device experience industry high preferred.
  • 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.

 

Additional Information