LAUNCH YOUR CAREER TODAY WITH ADVANTAGE TECHNICAL!

Are you ready to make a direct impact on the development of groundbreaking medical technologies? Advantage Technical is hiring a Quality Engineer in the Minneapolis, MN. This is your opportunity to develop your career and contribute to world-class healthcare solutions!

QUALIFICATIONS

• A bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or Electrical Engineering
• 2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Problem solver, capable of facilitating the problem-solving process
• Adaptable and effective collaborator in a team environment and self-directed work
• Strong communication skills (verbal & written)
• Ability to work in a highly matrixed and geographically diverse business environment

PREFERRED QUALIFICATIONS:

• Previous Software or Capital equipment Design Assurance experience is a plus
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971), and software standards (IEC 62304 or IEC 82304)
• Experience with 60601, software, and cybersecurity
• Experience working in an Agile environment

• Support the execution and documentation of Design Validation & Verification and Usability activities.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
• Update and maintain product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs).
• Lead and support cross-functional root-cause analysis investigation and resolution activities.
• Evaluate and support design, test, and inspection method development, and lead method validation activities.
• Support regulatory submissions to notified bodies.
• Understanding of technologies incorporated into design.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.