Principal Engineer

Job Title: Principal Engineer Location: Plymouth, MN (Onsite | Hybrid – Must be local and available 3+ days onsite/week)

Experience: 5 - 8 Years Citizenship Requirement: USC or Green Card holders only Duration: Through December 2026

Summary

Serve as the technical lead for sustaining engineering activities related to disposable medical devices, with a primary focus on maintaining and managing the Design History File (DHF) structure.

Key Responsibilities

Drive documentation strategy for new third-party suppliers supporting peritoneal dialysis disposable sets.

Manage change controls end-to-end—from initiation through execution.

Own the creation, maintenance, and accuracy of design history files.

Coordinate with global cross-functional teams to align R&D efforts and ensure seamless execution.

Lead and manage engineering projects, including planning, scheduling, and budgeting, with minimal supervision.

Ensure compliance with design control procedures, FDA regulations, ISO standards, and internal quality processes.

Required Qualifications

Strong experience supporting Class II or III disposable medical devices.

Proven background managing product support activities and change control processes.

Skilled in supplier documentation and records management.

Expertise in design output strategies across multiple product lines.

Familiar with design transfers from R&D to manufacturing environments.

Advanced understanding of FDA Design Controls and ISO 13485.

Working knowledge of ISO 14971 risk management for medical devices.

Strong initiative and ability to implement continuous improvement and best practices.

Capable of mentoring and coaching others with technical depth.

Excellent multitasking, communication, and cross-functional collaboration skills.

Fluent in English (written and verbal).

Education & Experience

BS in Mechanical, Plastics, Biomedical Engineering, or related field (MS preferred)

5–8 years of experience in medical device R&D, preferably with disposable products