SW Quality/Design Assurance Engineer - Med Device jobs in United States
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Horizontal Talent ยท 1 day ago

SW Quality/Design Assurance Engineer - Med Device

positionGolden Valley, MN
timeFull-time
remoteOnsite
senioritySenior Level
money$150K/yr - $170K/yr
date5+ years exp

Horizontal Talent is seeking a Software Quality Assurance Engineer to ensure the quality and integrity of medical device software. The role involves collaborating with development teams, ensuring compliance with standards, and leading audit activities to contribute to the development of life-changing technologies.

Business DevelopmentConsultingStaffing Agency
Hiring Manager
Benjamin Haymaker
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Responsibilities

Collaborate with development teams to create project deliverables and conduct thorough audits before product release
Ensure compliance with design history and regulatory standards by addressing gaps with cross-functional teams
Provide assurance services for software design, including validation planning and test system development
Support risk management activities from the product concept phase through to commercialization
Offer expertise on global standards for medical device software and security to ensure compliance
Assist in quality engineering for design changes and ongoing engineering projects
Lead internal and external audit activities and contribute to other quality initiatives as needed

Qualification

Medical device software qualityRisk management toolsMedical software design standardsASQ certificationsProject managementMicrosoft Office proficiencyBug tracking toolsClass III products

Required

Bachelor's degree in a technical or scientific field
At least 5 years of experience in medical device software quality or design assurance roles
Comprehensive understanding of medical software device design standards and global regulations
Proficiency with risk management tools and standards such as ISO14971 and IEC 62304
Strong project and time management skills with the capability to manage multiple tasks
Proficiency in Microsoft Word, Excel, and PowerPoint
Experience with Class III active implantable products

Preferred

Experience in software design reliability and product quality assurance functions
ASQ certifications such as CSQE, CRE, CQM, or CQE
Familiarity with bug tracking tools like JIRA
Experience with GHTF requirements for process validations

Benefits

Medical
Dental
Vision
Retirement

Company

Horizontal Talent

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Horizontal Talent provides staffing services for IT, digital marketing, and strategic markets.
dateFounded in 2003
location
Saint Louis Park, Minnesota, USA
people-size201-500 employees
web-link
http://www.horizontaltalent.com

Funding

Current Stage
Growth Stage

Leadership Team

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Jeremy Langevin
Co-Founder and CEO
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Company data provided by crunchbase