Project Engineer

Collabera; Plymouth (MN); On-site; USD 48,000 - 55,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid parking/public transportation

Job summary

Collabera is seeking an experienced Project Engineer in Plymouth, MN to lead sustaining engineering, supplier and design changes, and continuous improvement within a regulated medical device environment.

The role requires owning project scope, schedules, risks, milestones, and deliverables while coordinating cross-functional teams, governance, and change control to ensure quality system compliance and regulatory alignment.

Qualifications

• Bachelor's degree in Engineering or related field.
• Five years medical device experience in R&D, Manufacturing, or Quality Engineering.
• Experience leading cross-functional projects or workstreams.
• Experience with geographically diverse teams in a matrix organization.
• Excellent verbal and written communication across all levels.
• Ability to prioritize and manage multiple tasks.
• Proficiency in MS Office and project scheduling tools.
• Willingness to travel up to 10% domestically or internationally.

Responsibilities

• Lead sustaining engineering, supplier change, design change, and continuous improvement projects.
• Independently manage scope, schedules, milestones, risks, and deliverables.
• Coordinate cross-functional teams across multiple departments (R&D, Operations, Manufacturing, Quality, Regulatory, Supply Chain, Packaging, Labeling, Publications).
• Facilitate project meetings, track deliverables, and align stakeholders.
• Identify risks and issues, develop mitigation plans, coordinate resolution.
• Develop and maintain project plans, risk registers, dashboards, and reports.
• Communicate project status and key decisions to stakeholders.
• Support governance, resource planning, and leadership communications.
• Lead workstreams within broader initiatives while maintaining alignment with timelines.
• Manage Change Orders, procurement coordination, and project tracking systems.
• Utilize PLM, ERP, and project portfolio tools to support execution.
• Collaborate with suppliers and external stakeholders to resolve issues.
• Ensure activities comply with regulatory requirements and quality systems.

Skills

Cross-functional

Project management

Communication

Scheduling

Risk management

Procurement

Regulatory knowledge

Travel readiness

MS Office

Education

Bachelor's degree in Engineering

Master's degree (preferred)

PMP/CAPM certification (preferred)

Tools

MS Office

Project scheduling tools

Job description

Pay Range

$35/hr to $40/hr

Job Title

Project Engineer

Location

Plymouth, MN 55442

Work Type

Onsite

Contract Duration

12 Months, with possible extension based on performance and business needs

Job Summary

We are seeking an experienced Project Engineer to lead sustaining engineering, supplier change, design change, and continuous improvement projects within a regulated medical device environment. The ideal candidate will independently manage project scope, schedules, risks, milestones, and deliverables while coordinating cross functional teams. This role requires strong project leadership, stakeholder communication, and organizational skills to drive successful project execution. The candidate will support project governance, change control, procurement coordination, and strategic initiatives while ensuring compliance with applicable quality system requirements and regulatory standards.

Key Responsibilities

• Lead the planning, execution, and implementation of sustaining engineering, supplier change, design change, and continuous improvement projects.
• Independently manage project scope, schedules, milestones, risks, action items, and deliverables to achieve business objectives.
• Coordinate cross functional teams across Research and Development, Operations, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Packaging, Labeling, and Technical Publications.
• Facilitate project meetings, establish accountability, track deliverables, and maintain alignment among stakeholders.
• Identify project risks, issues, and dependencies, develop mitigation plans, and coordinate timely resolution.
• Develop and maintain project plans, schedules, risk registers, action item logs, status reports, dashboards, and project documentation.
• Communicate project status, risks, key decisions, and recommendations to stakeholders and management.
• Support project governance, resource planning, prioritization, performance metrics, and leadership communications.
• Lead assigned workstreams within larger strategic initiatives while ensuring alignment with project objectives and timelines.
• Manage Change Orders, procurement coordination, project reporting, and project tracking systems.
• Utilize product lifecycle management systems, ERP systems, project portfolio management tools, and purchasing systems to support project execution.
• Collaborate with suppliers and external stakeholders to facilitate project implementation and resolve operational issues.
• Ensure project activities comply with applicable regulatory requirements, quality systems, organizational policies, and standard operating procedures.

Required Qualifications

• Bachelor's degree in Engineering or a related field.
• Minimum of five years of medical device experience in Research and Development, Manufacturing, or Quality Engineering.
• Demonstrated experience leading cross functional projects or project workstreams.
• Experience collaborating with geographically diverse teams in a matrixed organization.
• Excellent verbal and written communication skills, including the ability to communicate with stakeholders at all organizational levels and external suppliers.
• Ability to initiate, prioritize, and coordinate multiple tasks simultaneously.
• Proficiency in MS Office applications, including Word, Excel, and PowerPoint, and experience with project scheduling tools.
• Ability to travel up to 10 percent domestically or internationally.

Preferred Qualifications

• Master's degree in a technical or business field.
• PMP, CAPM, or another project management certification.
• Familiarity with product lifecycle management systems, ERP systems, project portfolio management tools, and procurement platforms.
• Experience leading sustaining engineering, supplier change, or operations projects within a regulated industry.
• Experience with product lifecycle management activities, including Change Orders, documentation updates, supplier changes, and design transfer.
• Experience developing project metrics, dashboards, and leadership communications.
• Experience in regulated industries such as medical devices, pharmaceuticals, aerospace, or manufacturing.
• Knowledge of continuous improvement methodologies such as Lean, Six Sigma, or Kaizen.

Benefits

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)