Medical Device Project Engineer

Cynet Systems•Plymouth, MN

About The Position

The Project Engineer independently leads sustaining engineering, supplier change, design change, and continuous improvement projects, while supporting larger strategic initiatives across the Electrophysiology organization. The role plans, coordinates, and executes projects in accordance with project management methodologies and quality system requirements. Working with cross-functional teams, the Project Engineer manages project scope, schedules, risks, deliverables, and stakeholder communications to support successful execution and business objectives. The position drives project activities from initiation through implementation, provides leadership within matrixed teams, and contributes to project governance, reporting, and communications. Project work includes change order ownership, procurement coordination, project reporting, and maintenance of project tracking systems. The role also partners with suppliers and external stakeholders and ensures project activities comply with FDA regulations, applicable quality system requirements, company policies, and business unit operating procedures. Travel may be required up to 10% domestically and/or internationally.

Requirements

Bachelor's degree in engineering or a related field.
Minimum 5 years of medical device experience in R&D, Manufacturing, and/or Quality Engineering.
Excellent verbal and written communication skills, including the ability to communicate with all organizational levels, suppliers, and consultants.
Experience collaborating with cross-functional team members in a geographically diverse, matrixed organization.
Demonstrated experience leading cross-functional projects or project workstreams.
Ability to initiate, prioritize, and coordinate multiple tasks simultaneously.
Proficiency in MS Word, Excel, PowerPoint, and Project.
Ability to travel up to 10% domestically and/or internationally.

Nice To Haves

Master's degree in a technical or business field.
PMP, CAPM, or another project management certification.
Familiarity with Windchill, SAP, Planview, and Ariba.
Experience leading sustaining engineering, supplier change, or operations projects within a regulated industry.
Experience supporting product lifecycle management activities, including Change Orders (COs), documentation updates, supplier changes, and design transfer activities.
Experience developing project metrics, dashboards, and leadership communications.
Experience working in a regulated industry such as medical devices, pharmaceuticals, aerospace, or manufacturing.
Knowledge of continuous improvement methodologies such as Lean, Six Sigma, or Kaizen.

Responsibilities

Lead planning, execution, and implementation of sustaining engineering, supplier change, design change, and continuous improvement projects.
Manage project scope, schedules, milestones, risks, action items, and deliverables to support on-time completion and business objectives.
Lead cross-functional project teams involving R&D, Operations, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Packaging, Labeling, Technical Publications, and other stakeholders.
Facilitate project team meetings, drive accountability for deliverables, and maintain alignment across functional groups.
Identify project risks, issues, and dependencies; develop mitigation strategies and coordinate resolution activities.
Partner with functional team members and managers on resource planning, priority setting, and issue resolution.
Develop and maintain project plans, schedules, risk registers, action-item logs, and project documentation.
Communicate project status, risks, key decisions, and recommendations to stakeholders and management.
Support project governance by developing metrics, dashboards, status reports, and leadership communications.
Lead assigned workstreams within larger strategic initiatives and align work with overall project objectives and timelines.
Execute project support activities, including ownership of Change Orders (COs), procurement coordination, project reporting, and maintenance of tracking systems.
Use Windchill, SAP, Planview, Ariba, and other business systems to support project execution, reporting, portfolio visibility, and procurement.
Partner with suppliers and external stakeholders to support implementation and resolve issues.
Ensure project activities comply with FDA regulations, quality system requirements, company policies, and business unit operating procedures.