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About the role
Job Title: Sr. R&D Engineer Location: Minneapolis, MN
Experience: 3 - 5 years Duration: Through December 2026 Work Arrangement: Hybrid (Must be local and onsite)
Position Overview
The Senior R&D Engineer will support sustaining engineering activities for peritoneal dialysis disposable sets. This role involves working closely with suppliers, ensuring compliance with regulatory standards, and maintaining high-quality design documentation.
Key Responsibilities
Develop and maintain supplier documentation including design specifications, labeling, and design drawings
Create and update Design History Files (DHFs)
Conduct change control assessments and implement required updates
Collaborate with project managers and technical leads to meet project deliverables
Ensure all work aligns with FDA, ISO, and company design control procedures
Required Qualifications
Proven experience working with external manufacturers and suppliers
Skilled in creating and modifying medical device design outputs
Knowledge of design transfer processes from R&D to manufacturing
Strong understanding of FDA Design Controls, ISO 13485, and ISO 14971
Excellent communication, organizational, and problem-solving skills
Education & Experience
Bachelor’s degree in Mechanical, Plastics, or Biomedical Engineering (Master’s preferred)
3–5 years of experience in Class II or III disposable medical product development
Design for Six Sigma (DFSS) training/certification is a plus
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