Job Description
Job Description
We are seeking an experienced Project Engineer to lead sustaining engineering, supplier change, and continuous improvement projects within our Electrophysiology organization. This role is responsible for managing project timelines, risks, deliverables, and cross-functional communication while ensuring compliance with medical device quality systems and regulatory requirements.
The ideal candidate is a highly organized engineering professional with experience leading cross-functional teams in a regulated medical device environment. This individual will drive projects from initiation through implementation, collaborating with R&D, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Operations, and external suppliers to ensure successful execution and business continuity.
Key Responsibilities
- Lead sustaining engineering projects to support existing medical device products throughout their lifecycle.
- Manage supplier change initiatives, including qualification, risk assessment, validation activities, and implementation planning.
- Drive continuous improvement efforts focused on product quality, process efficiency, cost reduction, and supply chain resiliency.
- Develop and maintain project plans, schedules, budgets, and risk mitigation strategies.
- Coordinate activities across cross-functional teams to ensure project milestones and deliverables are achieved on time.
- Facilitate project meetings and communicate status updates, risks, issues, and decisions to stakeholders and leadership.
- Ensure compliance with applicable quality system requirements, FDA regulations, ISO 13485 standards, and internal procedures.
- Support design changes, engineering change orders (ECOs), verification and validation activities, and documentation updates.
- Partner with Quality and Regulatory teams to assess the impact of product and process changes.
- Identify opportunities for process improvements and implement best practices in project execution.
Required Qualifications
- Bachelor's degree in Engineering or a related technical field.
- 5+ years of medical device industry experience in R&D, Manufacturing Engineering, Quality Engineering, or a related function.
- Experience leading cross-functional projects, project workstreams, or engineering initiatives.
- Strong organizational, communication, and problem-solving skills.
- Demonstrated ability to manage multiple priorities in a fast-paced, regulated environment.
- Proficiency with Microsoft Office applications, including Excel, PowerPoint, and Microsoft Project.
- Ability to travel up to 10% domestically and/or internationally.
Preferred Qualifications
- PMP (Project Management Professional) or CAPM certification.
- Experience with supplier change management, sustaining engineering, or product lifecycle management activities.
- Familiarity with engineering and enterprise systems such as:
- Windchill
- SAP
- Planview
- Ariba
- Experience working within FDA-regulated and ISO 13485-certified environments.
- Knowledge of risk management methodologies and change control processes.
Benefits
Health care insurance benefits available first of the month following 60 days of employment. Thirty (30) hours worked per week must be averaged in order to maintain coverage. 401k enrollment is available per the Secure Act guidelines. Earned Sick and Safe time is accrued and can be used per the State of MN guidelines.