Brio Group · 2 weeks ago
Senior Design Assurance Engineer
Twin Cities Area
Full-time
Onsite
Senior Level
5+ years expBrio Group is seeking a Senior Design Assurance Engineer to support product development and ensure high-quality product delivery. The role involves collaborating with various teams and maintaining compliance with quality management systems.
BiometricsBusiness DevelopmentLife ScienceRecruitingStaffing Agency
Hiring Manager
Meagan Corradi
Responsibilities
Support and execute product development deliverables
Develop and maintain Design History File (DHF) documentation that is complete, accurate, and compliant
Help define and maintain customer requirements, product requirements, and specifications
Lead and support product risk management activities
Write design verification and validation plans and reports
Support sampling inspection plans and qualification of purchased components
Contribute to test method development and lead method validation
Use statistical tools to support characterization, verification, validation, and root cause analysis
Support quality system activities, including non-conformances and CAPAs
Perform other related duties as needed
Qualification
Required
Bachelor's degree in engineering
5+ years of engineering or quality experience in the medical device industry
Ability to work independently with limited supervision
Strong understanding of Quality Systems and documentation practices
Experience with CAPA investigations and implementation
Experience with design controls and test method validation
Familiarity with EU MDR, FDA 21 CFR, TGA regulations, ISO 14971, and ISO 13485
Strong written and verbal communication skills
Comfortable collaborating with multidisciplinary engineering teams
Company
Brio Group
"Hire Possibilities" Brio Resource Group - Your biopharmaceutical recruiting experts - is transforming the way today's most sought after "A" Talent is introduced and placed in strategic roles with desirable companies.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$0.26MKey Investors
National Science Foundation
2022-06-01Grant· $0.26M
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