Share Email Opening Apply Now Title Design Assurance Specialist  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.   About the Organization We are a dedicated and multidisciplinary group of problem solvers with decades of engineering expertise. As a leader in complex catheter development we have assembled a team of world class engineers that don't shy away from challenges.   Position Design Assurance Specialist   Description Description: The Design Assurance specialist role supports design assurance throughout the product lifecycle. Design Assurance works with the development / engineering teams to ensure that devices are designed in accordance with product requirements as well as ISO 13485, ISO 14971 and 21 CFR 820 requirements. Duties and Responsibilities: DA Responsibilities Works closely with engineering and quality assurance to ensure quality records are complete – performs review of all quality records for requirements of SP0023 Assists engineering and quality assurance with product development project tasks as assigned Contributes to project design and development documentation deliverables Document Control Understand and apply Documentation and Record Retention principles and processes to ensure compliance with regulatory requirements Assist with necessary administrative roles within Grand Avenue for document control as needed for the engineering group Maintenance of project related Design History Files, as required Quality Systems Review quality records, including lot history records, inspection forms and returned product records to ensure GDP requirements are met Provides Quality Systems training for incoming engineering team members Grand Avenue basic training DCR prep training Documentation / GDP basics   Position Requirements Education, Experience, and Skills 3+ years of work experience in the medical device industry. Experience with ISO 13485, and FDA 21 CFR part 820. Proficient computer skills (MS Office, Excel). Good verbal and written communication skills. Must be detail-oriented and able to work independently. Compensation & Benefits Salary range: $21.00 - $28.00 per hour The following benefits are available to full-time employees: 120 hours of paid time off 9 paid company holidays Health, Dental, & Vision coverage Short- & Long-term disability opt-in Health Savings Account (HSA) & employer contribution 401(k) & employer contribution   Exempt/Non-Exempt Non-Exempt   Full-Time/Part-Time Full-Time   Open Date 4/27/2026   This position is currently accepting applications. Apply Now WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles Product Development Engineer III in Maple Grove, MN Posted on: 1/28/2026 [Apply Now] Production Operator in Maple Grove, MN Posted on: 4/27/2026 [Apply Now]

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