Medical Device Project Engineer

Cynet Systems•Plymouth, MN

About The Position

Our client is seeking an experienced, results-oriented Project Engineer to independently lead 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 using project management methodologies and in accordance with quality system requirements. The Project Engineer partners with cross-functional teams to manage scope, schedules, risks, deliverables, and stakeholder communications to achieve business objectives. The successful candidate drives project activities from initiation through implementation, provides leadership within matrixed project teams, and contributes to project governance, reporting, and communications. The role also supports project workstreams, change orders, procurement coordination, project tracking, and supplier engagement. Project activities must comply with FDA regulations, applicable quality system requirements, company policies, and business unit operating procedures.

Requirements

Bachelor's degree in engineering or a related field.
At least 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 in 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 the 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 timely completion and alignment with 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 ensure 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 project resource planning, priority setting, and issue resolution.
Develop and maintain project plans, schedules, risk registers, action-item logs, and other project documentation.
Communicate project status, risks, key decisions, and recommendations to stakeholders and management.
Support project governance by developing project metrics, dashboards, status reports, and leadership communications.
Lead assigned workstreams within larger strategic initiatives while maintaining alignment with overall project objectives and timelines.
Own Change Orders (COs), coordinate procurement, prepare project reporting, and maintain project 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 project implementation and resolve issues.
Ensure project activities comply with FDA regulations, applicable quality system requirements, company policies, and business unit operating procedures.