Medical Device Manufacturing Engineer jobs in United States
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Radiant Dev · 10 hours ago

Medical Device Manufacturing Engineer

positionSeattle, WA
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
money$100K/yr - $115K/yr
date8+ years exp

Radiant Dev is seeking a hands-on quality assurance engineer with strong manufacturing and quality systems experience. This role involves managing key elements of the Quality Management System and improving product quality, cost, and manufacturability.

DevOpsMobile AppsSoftwareUX Design
Hiring Manager
Skylar Small
linkedin

Responsibilities

Lead investigations and manage dispositions for all manufacturing nonconformances
Review, optimize, and validate manufacturing processes for quality and regulatory compliance
Own tooling and equipment qualification and calibration
Manage supplier quality, including evaluations, audits, and SCARs
Drive internal CAPAs tied to manufacturing issues
Track production data, identify trends, and drive continuous improvement efforts
Train and support the team on QMS processes, GMP, and process controls
Maintain and improve manufacturing documentation, inspection procedures, and Device History Records

Qualification

Quality Management System (QMS)Manufacturing experienceRoot cause analysisISO 13485Technical writingClear communicatorDetail-orientedCollaborative team player

Required

Bachelor's degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering; or 8+ years of relevant experience
3+ years in a regulated environment (medical devices preferred)
Clear, concise technical writing skills
Working knowledge of QMS elements such as CAPA, Training, Nonconformance, and Change Control
Familiarity with ISO 13485
Comfortable supporting internal and external audits

Preferred

Practical experience in manufacturing and quality engineering
Detail-oriented mindset with a focus on mistake-proofing
Solid engineering fundamentals: materials, manufacturing, test methods, and root cause analysis
Clear communicator with both technical and nontechnical stakeholders
Collaborative team player and proactive problem solver

Benefits

Medical insurance
Dental reimbursement
15 days of paid time off (PTO) plus federal holidays
401(k) plan with both pre-tax and Roth options

Company

Radiant Dev

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Radiant Dev is a software company that provides web apps and mobile app services.
dateFounded in 2009
location
Boulder, Colorado, USA
people-size11-50 employees
web-link
https://www.radiant.dev

Funding

Current Stage
Early Stage

Leadership Team

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Molly Gravatt
Founder
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Company data provided by crunchbase