Intellectt Inc · 3 days ago
Senior Research And Development Engineer
Irvine, CA
Contract
Onsite
Senior Level
5+ years expIntellectt Inc is seeking a Senior Research And Development Engineer to collaborate with R&D and Operations teams on various engineering processes. The role involves optimizing manufacturing and R&D processes, leading risk management, and providing technical input for project plans to support product development.
Information TechnologyRecruitingStaffing Agency
Hiring Manager
Mohammed Shuja
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
Qualification
Required
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
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
Intellectt Inc
We advance technology with purpose - empowering enterprises move confidently into the future.
1001-5000 employees
H1B Sponsorship
Intellectt 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 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)
Funding
Current Stage
Late StageCompany data provided by crunchbase