Project Engineer - Medical

Job Title: Project Engineer
Location: Plymouth, MN 55442
Work Mode: Fully onsite (may be hybrid temporarily; long-term onsite)
Industry: Medical device industry

Job Description:

We are seeking an experienced Project Engineer to lead sustaining engineering, supplier change, design change, and continuous improvement projects within the Electrophysiology organization. The candidate will coordinate cross-functional teams and manage project schedules, risks, deliverables, and stakeholder communications to ensure successful project execution.

Key Responsibilities:

• Lead sustaining engineering, supplier change, design change, and continuous improvement projects.

• Manage project scope, schedules, milestones, risks, action items, and deliverables.

• Coordinate cross-functional teams across R&D, Manufacturing, Operations, Quality, Regulatory Affairs, and Supply Chain.

• Facilitate project meetings, track progress, and ensure accountability for deliverables.

• Identify project risks and develop mitigation plans.

• Prepare project plans, dashboards, status reports, and management updates.

• Manage Change Orders (COs), procurement coordination, and project documentation.

• Use systems such as Windchill, SAP, Planview, and Ariba to support project execution.

• Ensure compliance with FDA regulations, quality systems, and company procedures.

• Support suppliers and larger strategic initiatives.

Required Qualifications:

• Bachelor's degree in Engineering or a related field.

• Minimum 3 years of medical device experience in R&D, Manufacturing, or Quality Engineering.

• Experience leading cross-functional projects or project workstreams.

• Strong communication, organizational, leadership, and problem-solving skills.

• Proficiency in MS Word, Excel, PowerPoint, and Project.

• Ability to manage multiple priorities in a fast-paced, matrixed environment.

• Willingness to travel up to 10% domestically and/or internationally.

Preferred Qualifications:

• Master's degree in a technical or business field.

• PMP, CAPM, or other project management certification.

• Experience with Windchill, SAP, Planview, or Ariba.

• Experience with sustaining engineering, supplier changes, Change Orders, design transfer, or product lifecycle management.

• Knowledge of Lean, Six Sigma, or Kaizen methodologies.

• Experience in regulated industries such as medical devices, pharmaceuticals, or aerospace.