Job Title: Manufacturing Quality Engineer

Location: St. Paul, MN - 55117

Duration: 12 Months

What You’ll Work On:

• Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.
• Support Test and Inspection Method development including Method Validation activities.
• Support Design Verification and Design Validation planning and execution , including cross-functional root-cause analysis investigation and resolution activities.
• Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
• Own Corrective Action/Preventive Action (CAPA) investigations.

Required Qualifications:

• Bachelor’s degree within an Engineering field or a closely related discipline.
• 5-8+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.

Preferred Qualifications-Can Modify

• Bachelor’s or advanced degree in Mechanical or Biomedical Engineering
• Prior experience with Cardiovascular medical devices
• Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.