Compunnel Inc. · 2 days ago
Senior R&D Quality Engineer-- KAUDC5698989
Irvine, CA
Contract
Onsite
Mid, Senior Level
$63/hr - $65/hr
3+ years expCompunnel Inc. is seeking a Senior R&D Quality Engineer to support R&D and New Product Development projects within the Design Assurance/Quality Engineering team. The role involves ensuring product quality, patient safety, and regulatory compliance throughout the product lifecycle, collaborating closely with R&D, Operations, and Manufacturing.
Information Technology & Services
Hiring Manager
Kasak Tyagi
Responsibilities
Support two active projects:
Project 1: manufacturing process qualifications and build support (commercialization phase)
Project 2: early-phase new product development focused on design & development activities
Collaborate with R&D and Operations on design controls, verification/validation, test methods, and risk management
Lead and maintain risk management documentation (including FMEAs) aligned to ISO 14971
Investigate product and process quality issues; support root-cause analysis using Six Sigma/DMAIC tools
Contribute to project plans, timelines, and documentation to support regulatory approvals
Support process validation, test method validation, and statistical analysis (Minitab preferred)
Help ensure compliance with federal, local, and company quality system requirements
Mentor and collaborate with cross-functional teams; coordinate activities with engineers/technicians
Balance daily work across ~60% desk / 40% manufacturing floor
Qualification
Required
Experience qualifying products and processes in medical device manufacturing
Hands-on Quality Engineering in regulated environments (preferably Class III devices)
Experience across multiple phases of product development (concept → launch)
Comfortable managing multiple projects at once
Strong analytical, problem-solving, and communication skills
Ability to interpret drawings, schematics, and technical documentation
Knowledge of design controls, risk management, and verification/validation
Team-oriented with attention to detail; ability to mentor and collaborate effectively
Bachelor's degree (Engineering preferred, others considered with relevant experience)
3–10 years of engineering experience, ideally in Quality, R&D, or Product Development within medical devices
Preferred
Familiarity with process validations and statistical tools (Minitab is a plus)
Cleanroom exposure is helpful (not required)
CAD or engineering software experience preferred
Company
Compunnel Inc.
Compunnel Inc. is where AI-native solutions meet human ingenuity, helping enterprises reimagine talent, technology, and growth.
5001-10000 employees
H1B Sponsorship
Compunnel Inc. 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 (2276)
2024 (1682)
2023 (1992)
2022 (2366)
2021 (2223)
2020 (2220)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase