Design Assurance Engineer

Design Assurance Engineer

Company: High-Growth Interventional Medical Device Company
Location: Minneapolis, MN
Employment Type: Permanent
Level: Multiple levels may be considered

The Opportunity

Brio Resource Group is partnering with a growing medical device company to identify an experienced Design Assurance Engineer.

This position will support the development, qualification, and commercialization of innovative vascular-access and interventional medical devices. Serving as the Quality representative on cross-functional product-development teams, the successful candidate will ensure products are developed in accordance with design controls, risk-management requirements, regulatory standards, and internal quality procedures.

Key Responsibilities

  • Serve as the Design Assurance representative on new-product development and design-change projects.
  • Guide programs through design planning, inputs and outputs, design reviews, verification, validation, design transfer, and Design History File completion.
  • Draft, review, and approve specifications, drawings, product requirements, protocols, reports, test methods, and engineering documentation.
  • Lead or support product risk-management activities in accordance with ISO 14971.
  • Develop hazard analyses, design FMEAs, use-related risk assessments, and risk-management reports.
  • Ensure risk-control measures are incorporated into product requirements, verification activities, labeling, and manufacturing controls.
  • Develop risk-based verification and validation strategies in partnership with Engineering and Regulatory Affairs.
  • Support design verification, design validation, test-method validation, equipment qualification, and process validation.
  • Evaluate design changes for quality, regulatory, manufacturing, and patient-safety implications.
  • Support design transfer by ensuring product and process requirements are appropriately verified and incorporated into manufacturing documentation.
  • Maintain accurate, complete, and inspection-ready design-history and risk-management files.
  • Support investigations involving nonconformances, deviations, CAPAs, complaints, and supplier-quality issues related to product design.
  • Participate in internal and external audits and support responses to FDA or notified-body questions.
  • Partner with R&D, Manufacturing, Operations, Regulatory Affairs, and suppliers to resolve technical and quality issues.
  • Support post-market product safety and performance through complaint investigations and risk-management updates.

Qualifications

  • Bachelor’s degree in engineering, science, or another relevant technical discipline.
  • At least three years of experience in medical-device quality, Design Assurance, product development, or a related engineering function.
  • Working knowledge of medical-device design controls and risk-management principles.
  • Experience developing or reviewing design-control documentation, risk analyses, verification protocols, and technical reports.
  • Strong technical-writing, documentation, analytical, and problem-solving capabilities.
  • Ability to evaluate complex technical information and communicate Quality requirements clearly to cross-functional teams.
  • Practical, solutions-oriented approach to quality, compliance, and risk-based decision-making.
  • Ability to work independently, take ownership, and collaborate across traditional functional boundaries.
  • Strong attention to detail with the ability to manage competing priorities in a growing organization.

Preferred Experience

  • Catheter-based, guidewire, vascular, neurovascular, or other interventional medical-device experience.
  • Knowledge of FDA QSR/QMSR, ISO 13485, ISO 14971, and applicable FDA guidance.
  • Experience supporting 510(k) submissions or responding to FDA questions.
  • Experience with test-method validation, process validation, equipment qualification, and statistical analysis.

Why Consider This Opportunity?

This role offers the opportunity to influence product quality and patient safety throughout the complete development lifecycle, work closely with experienced technical and regulatory teams, and help commercialize innovative vascular and interventional medical devices within a growing organization.

A complete job description, compensation information, benefits, and additional company details will be provided following an initial résumé review.