Sira Consulting, an Inc 5000 company · 10 hours ago
Design Quality Engineer
Plano, TX
Contract
Onsite
Senior Level
6+ years expSira Consulting, an Inc 5000 company, is seeking a Design Quality Engineer with extensive experience in medical devices. The role involves managing design quality processes, ensuring compliance with regulations, and collaborating with cross-functional teams to support product development and risk management activities.
EducationDigital MediaAppsContentMobile AppsTrainingWeb Design
Responsibilities
6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development
Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations
Experience in compiling Design history files & Technical file submission for 510k & CE mark
Own Risk Management files – Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report
Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation
Review & approve all the design history files with cross functional teams (including software deliverables)
Support product development equipment qualification activities, test method development and validation activities
Strong in Medical devices technical documentation
Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Strong analytical/problem solving, critical thinking, and presentation skills
Qualification
Required
6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development
Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations
Experience in compiling Design history files & Technical file submission for 510k & CE mark
Own Risk Management files – Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report
Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation
Review & approve all the design history files with cross functional teams (including software deliverables)
Support product development equipment qualification activities, test method development and validation activities
Strong in Medical devices technical documentation
Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Strong analytical/problem solving, critical thinking, and presentation skills
Company
Sira Consulting, an Inc 5000 company
SiRA Consulting is a Certified MBE consulting company that was founded in 2012.
201-500 employees
H1B Sponsorship
Sira Consulting, an Inc 5000 company 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 (14)
2024 (50)
2023 (42)
2022 (63)
2021 (86)
2020 (70)
Funding
Current Stage
Growth StageCompany data provided by crunchbase