MDR/Vigilance Specialist

Location: Mounds View, MN (Onsite 4 days/week) | Position Type: Contract (12 Months)

About the Role

We are seeking an experienced MDR/Vigilance Specialist to join our Quality Assurance and Regulatory Compliance team supporting Cardiovascular Surgery products. This role focuses on optimizing post-market vigilance processes, mapping complaint codes, updating critical quality documentation, and coordinating cross-functional quality initiatives. The ideal candidate brings 3 to 5 years of experience in medical device complaint handling, strong technical communication, and proven project management skills.

Responsibilities

• Analyze customer complaints and accurately map complaint codes to defined categories (utilizing IMDRF frameworks where applicable).
• Author, update, and standardize Work Instructions (WIs) and Standard Operating Procedures (SOPs) to reflect updated compliance and coding directives.
• Partner with Quality Engineering, Regulatory Affairs, R&D, and Operations to drive vigilance alignment and complaint resolution.
• Track deliverables, prioritize tasks, and manage timelines for process updates and quality improvement initiatives.
• Apply medical device testing standards, risk principles, and specification knowledge to daily vigilance workflows.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical discipline with 2+ years of work experience in Engineering and/or Quality OR an Advanced degree in a technical field.
• 3–5 years of direct experience in medical device quality, complaint handling, or post-market surveillance.
• Direct experience in medical device complaint handling procedures.
• Strong project management skills with the ability to manage multiple priorities in a dynamic environment.
• Ability to work onsite 4 days per week at the Mounds View, MN facility.

Preferred Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering or a related engineering field.
• Knowledge or understanding of IMDRF complaint coding structure.
• Experience supporting Cardiovascular Surgery or complex medical device product lines.
• Familiarity with medical device design, statistical methods (design reliability, process capability), specification development, and Geometric Dimensioning & Tolerancing (GD&T).
• Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or equivalent quality certifications.
• Excellent written and oral communication skills, polished presentation skills, and a demonstrated ability to build consensus across cross-functional teams.