Lead Design Assurance & Quality Engineer in Irvine

Job Overview:

Pay Range: $51.82hr - $56.82hr

Responsibilities:

• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
• Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyse results, and make recommendations.
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement.
• Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Lead Risk Management process for project in compliance with appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971.
• Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
• Strong leadership and collaboration with other leaders in project and across the organization.
• Mentor engineers in understanding of quality systems and strategies within new product development.
• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.).
• Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.
• Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
• Train, coach, and guide lower-level employees on more complex procedures.
• Oversee Quality support tasks; give instruction to engineers/technicians on conducting tests; train engineers/technicians and provide feedback; and may coordinate engineers/technician work.

Skills:

• Creativity, verbal and written communication skills, analytical and problem-solving ability.
• Team player and detail-oriented.
• Basic leadership and mentoring skills necessary to provide support and constructive performance feedback.
• Ability to read and interpret blueprints, technical drawing, schematics, and computer-generated reports.
• Previous experience with computer applications and software related to the engineering field, such as Computer Aided Design (CAD).

Education/Experience:

• Bachelor's degree in engineering required.
• 5-7 years experience required.