Project Engineer, Medical Devices — Sustaining & CI Lead

Select Source International; Plymouth (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Select Source International in Plymouth, MN seeks a Project Engineer to lead sustaining engineering, supplier changes, and continuous improvement initiatives within a medical device context. You will independently manage scope, schedules, risks, and deliverables, partnering with R&D, Operations, Manufacturing, Quality, Regulatory, and supply chain groups to meet business goals.

The role requires 5+ years in medical devices, strong communication, and the ability to work across diverse teams.

Qualifications

• Bachelor's degree in engineering or related field is required.
• Minimum 5 years of medical device experience in R&D, Manufacturing and/or Quality Engineering.
• Excellent verbal and written communication skills, with the ability to communicate to all levels of the organization as well as 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.
• Proficient in MS Word, Excel, PowerPoint, and Project.
• Ability to travel up to 10% of the time domestically and/or internationally.

Responsibilities

• Lead the planning, execution, and implementation of sustaining engineering, supplier change, design change, and continuous improvement projects in accordance with project management methodologies.
• Independently manage project scope, schedules, milestones, risks, action items, and deliverables to ensure projects are completed on time and aligned with business objectives.
• Lead cross-functional project teams including R&D, Operations, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Packaging, Labeling, Technical Publications, and other functional stakeholders.
• Facilitate project team meetings, drive accountability for project 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 to support project 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 project stakeholders and management.
• Support project governance activities through development of project metrics, dashboards, status reports, and leadership communications.
• Lead assigned workstreams within larger strategic initiatives while ensuring alignment with overall project objectives and timelines.
• Execute project support activities including ownership of Change Orders (COs), procurement coordination, project reporting, and maintenance of project tracking systems.
• Utilize Windchill, SAP, Planview, Ariba, and other business systems to support project execution, reporting, portfolio visibility, and procurement activities.
• Partner with suppliers and external stakeholders to support project implementation activities and issue resolution.
• Ensure project activities comply with FDA regulations, applicable quality system requirements, Company policies, and Business Unit operating procedures.

Skills

Communication skills

Cross-functional collaboration

Project leadership

Multitasking

MS Word

Excel

PowerPoint

Project

Education

Bachelor's degree in engineering or related field

Master's degree in technical or business field

Tools

MS Word

Excel

PowerPoint

Project

Windchill

SAP

Planview

Ariba

Job description

Select Source International in Plymouth, MN seeks a Project Engineer to lead sustaining engineering, supplier changes, and continuous improvement initiatives within a medical device context. You will independently manage scope, schedules, risks, and deliverables, partnering with R&D, Operations, Manufacturing, Quality, Regulatory, and supply chain groups to meet business goals.

The role requires 5+ years in medical devices, strong communication, and the ability to work across diverse teams.