SIMARN Solutions · 2 months ago
Sr. Design Quality Engineering
Irvine, CA, US
Full-time
Hybrid
Senior Level
$50/hr - $50/hrSIMARN Solutions is seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk management activities, and leading verification and validation processes. The role requires strong collaboration with cross-functional teams, hands-on involvement in design control, and the ability to resolve quality issues through structured problem-solving and risk-based approaches.
ConsultingInformation TechnologySoftware
Responsibilities
Ensure quality engineering activities meet regulatory and internal standards
Create and maintain product risk management documentation (Risk Plans, DFMEA, Risk Assessments, Risk Reports)
Support development and execution of V&V plans, protocols, and reports
Perform Test Method Validation and process validation (PFMEA, IQ, OQ, PQ)
Use statistical tools such as Minitab for data analysis
Oversee product testing to ensure compliance with applicable requirements
Apply Design Control principles to support sustaining engineering and product updates
Resolve quality issues and support design changes with cross-functional teams
Apply risk management techniques to identify and mitigate product risks
Use structured problem-solving methodologies to address product and process challenges
Prepare technical documentation, reports, and presentations for stakeholders
Qualification
Required
Experience with quality engineering in manufacturing or medical device environments
Strong knowledge of design control, risk management, and process validation
Hands-on experience with DFMEA, PFMEA, V&V activities, and statistical tools (Minitab)
Ability to support sustaining engineering and design updates
Strong analytical, communication, and problem-solving skills
Experience collaborating with engineering, manufacturing, and quality teams
Company
SIMARN Solutions
Simarn Solutions delivers IT solutions and services.
Founded in 2009
51-200 employees
H1B Sponsorship
SIMARN Solutions 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 (8)
2023 (15)
2022 (21)
2021 (18)
2020 (7)
Funding
Current Stage
Growth StageCompany data provided by crunchbase