Brio Group
The Design Assurance Engineer supports product development to ensure smooth production launch and high-quality product delivery. The role also assists with design changes and broader quality initiatives. It works closely with Engineering, Operations, Quality, Marketing, and Regulatory teams and is responsible for following all Quality Management System and safety requirements.
Location:
Must be able to work onsite in Burnsville.
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.
Qualifications
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Quality Assurance, and Design
Medical Equipment Manufacturing and Engineering Services
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Location:
Must be able to work onsite in Burnsville.
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.
Qualifications
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering, Quality Assurance, and Design
Medical Equipment Manufacturing and Engineering Services
#J-18808-Ljbffr