SPECTRAFORCE · 14 hours ago
Sr. Design Quality Engineer
Irvine, CA
Contract
Onsite
Senior Level
$52/hr - $57/hr
5+ years expSPECTRAFOR is seeking a Sr. Design Quality Engineer to research and test the design, functionality, and maintenance of products. The role involves collaborating with R&D and Operations teams to ensure product quality and compliance with standards, while also leading risk management processes.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Lakshay Kumar
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, analyze 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 to 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; gives instruction to engineers/technicians on conducting tests; trains engineers/technicians and provides feedback; and may coordinate engineers/technician work
Qualification
Required
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 engineering field, such as Computer Aided Design (CAD)
Bachelor's degree in engineering required
5-7 years experience required
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase