Millennium Software and Staffing Inc · 6 hours ago
Design Quality Engineer
Plano, TX
Contract
Onsite
Senior Level
5+ years expMillennium Software and Staffing Inc is seeking a Sr. Design Quality Engineer to lead Design Control and Risk Management activities for medical device development. This role is critical in ensuring new products conform to FDA and ISO standards while protecting patient safety.
Human ResourcesInformation TechnologySoftwareStaffing AgencyWeb AppsWeb Hosting
Responsibilities
Lead Design Control and Risk Management activities for medical device development
Ensure new products conform to FDA and ISO standards
Protect patient safety
Qualification
Required
5+ years of Quality Engineering experience (Medical Device industry preferred)
Design Control Expertise: Hands-on experience with Design Verification, Validation, and DHF integrity
Risk Management Lead: Skilled in FMECA, hazard analysis, and maintaining Risk Management Plans
Regulatory Knowledge: Working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
Technical Skills: Strong analytical/statistical skills and experience with equipment qualification
Preferred
If you have a strong background in implantable medical devices and a passion for engineering compliance, we want to hear from you
Company
Millennium Software and Staffing Inc
Millennium Software and Staffing Inc is a Minority and Woman owned IT Consulting and services organization.
501-1000 employees
H1B Sponsorship
Millennium Software and Staffing 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 (80)
2024 (50)
2023 (65)
2022 (39)
2021 (28)
2020 (106)
Funding
Current Stage
Late StageCompany data provided by crunchbase