MDR - MDR​/Vigilance Specialist - Exempt

Join our team in Mounds View, MN, where you will play a crucial role in ensuring the safety and compliance of our cardiovascular surgery products. This is an exciting opportunity to work onsite and collaborate with a dynamic cross-functional team.

• Bachelor's Degree in Engineering, Science, or a technical field with 2 years of work experience in Engineering and/or Quality OR an Advanced degree in Engineering, Science, or a technical field in Engineering and/or Quality.

• Bachelor's or Master's Degree in Mechanical Engineering, or other related engineering degree strongly preferred.
• Experience in medical device design and application of test standards.
• Experience in applying statistical methods to design reliability and process capability.
• Certified Quality Engineer, Reliability Engineer, or equivalent desired.
• Strong oral and written communication skills.
• Effective cross-functional team player with excellent presentation skills.
• Ability to handle multiple tasks/projects and manage priorities accordingly.
• Working knowledge of appropriate industry standards.
• Ability to work in a team environment and exert influence without alienating others.
• Knowledge/basic understanding of specification development, industry standards, geometric dimensioning, and tolerancing (GD&T), etc.

Responsibilities may include the following and other duties may be assigned:

• Monitor the company's drug or medical devices surveillance program, including the intake, protocol development, evaluation, processing, and follow-up on adverse reports.
• Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of ADE data and integrate the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization, as well as to ensure the accuracy and quality of safety summaries.
• Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

• Complaint handling experience and knowledge of IMDRF or complaint coding is a plus.
• Map complaint code to categories and update work instructions accordingly.
• Work with a cross-functional team.

3-5 years of relevant experience.

We are looking to hire and start ASAP, with interviews commencing immediately. The role requires onsite work in Mounds View, MN, 4 days a week.