Senior Design Quality Engineer to serve as the lead quality authority embedded within cross-functional medical device R&D teams. Acting as the critical bridge between product design and manufacturing, you will provide independent engineering and quality oversight across Design Controls, ISO 14971 product risk management, Design Verification & Validation (V&V), requirements traceability, and design transfer into production.
location: St. Petersburg, Florida
job type: Contract
salary: $68 - 80 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Guide the engineering team through formal Design Reviews, ensuring traceability from User Needs to Design Inputs/Outputs and V&V acceptance.
- Facilitate and build Hazard Analyses, Design FMEAs (dFMEA), and Process FMEAs (pFMEA) in accordance with ISO 14971.
- Write, review, and approve physical test protocols and reports for Design Verification, Test Method Validation (TMV / Gage R&R), and packaging/reliability testing.
- Review mechanical blueprints, GD&T, and tolerance stack-ups to identify Critical-to-Quality (CTQ) features and ensure the device can actually be manufactured reliably.
- Keep all NPI (New Product Introduction) programs strictly compliant with FDA 21 CFR Part 820 and ISO 13485.
- BS in Mechanical Engineering, Biomedical Engineering, or Quality Engineering (candidates must possess the mechanical foundation to read blueprints, understand material behaviors, and evaluate tolerances)
- Must have 7 + years experience in the regulated medical device Industry
- Must have a deep working knowledge of ISO 13485 & FDA CFR Part 820
- Hands-on experience with physical devices (Class I, Class II, or Class III, Durable Medical Equipment, electromechanical, or disposable surgical/delivery devices).
- Must have cross-functional collaboration experience
- Must have personally authored, reviewed, or approved Design Verification (DV) test protocols, reports, and dFMEAs under ISO 14971
- Proven experience translating R&D prototypes into manufacturing readiness
skills:
requirements traceability,Design Quality,Design Controls,Design Verification,ISO 14971,manufacturing,product design,R&D,risk management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
