Project Engineer

  • Kleen Test
  • Port Washington, Wisconsin
  • Full Time
Project EngineerPosition Overview We are seeking a Project Engineer to lead and deliver electromechanical projects from concept through commissioning. The role focuses on coordinating design and documentation, managing contract manufacturing relationships, developing automation and control solutions, and ensuring compliance within regulated environments (e.g., medical device, pharmaceutical, or other quality-regulated sectors). The ideal candidate combines strong technical skills in electromechanical systems, AutoCAD proficiency, practical experience with automation and controls, and the ability to drive projects on time and on budget while maintaining regulatory compliance.Key ResponsibilitiesLead project planning and execution across the full project lifecycle: requirements, design, procurement, build, test, validation, and handover.Develop and review electromechanical designs using AutoCAD and related CAD tools; create clear assembly and installation documentation.Specify, design, integrate, and commission automation and control systems (PLCs, HMIs, drives, sensors) in collaboration with internal teams and vendors.Manage relationships with contract manufacturers and suppliers, including technical clarifications, supplier selection, RFQs, and quality oversight during builds.Create and maintain technical documentation required for regulated environments: design history files, validation protocols, test plans, traceability matrices, and change control records.Coordinate factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, and operator training.Perform risk assessments (FMEA), root cause analysis, and drive corrective actions to resolve design or manufacturing issues.Ensure projects meet schedule, budget, and performance targets; report progress and escalate risks to stakeholders.Collaborate with quality, regulatory, manufacturing, and service teams to ensure solutions meet applicable standards and regulatory requirements.Support continuous improvement initiatives by recommending design, process, and automation enhancements to increase reliability, manufacturability, and cost-effectiveness.QualificationsBachelors degree in Mechanical, Electrical, Electromechanical Engineering, or related engineering discipline.3+ years of hands-on project engineering experience in electromechanical systems; experience in regulated industries (medical device, pharmaceutical, life sciences) preferred.Proven AutoCAD proficiency and experience producing fabrication and assembly drawings.Practical experience with automation and controls: PLC programming, HMI design, motor control, I/O specification, and system integration.Experience working with contract manufacturers and managing supplier technical requirements and quality expectations.Familiarity with regulatory and quality systems relevant to regulated environments (e.g., ISO 13485, FDA QSR, cGMP) and experience supporting design controls and validation activities.Strong project management skills: scheduling, budget tracking, risk management, and stakeholder communication; PMP or equivalent is a plus.Excellent problem-solving, written and verbal communication skills, and the ability to work cross-functionally and independently.Willingness to travel to supplier sites and customer locations for commissioning and testing as required.Benefits- Comprehensive medical, dental, and prescription drug coverage.- Free basic life, AD&D insurance, and company-funded short and long-term disability coverage, with voluntary options.- Flexible Spending Accounts for medical and dependent care.- Free financial wellness counseling and tools.- 401(k) retirement plan with employer match and paid vacation time that increases with seniority.- Employee Assistance Program, paid holidays, and time off for preventive care appointments.- Continuing education opportunities, tuition reimbursement, and gym membership discounts.
Job ID: 521568488
Originally Posted on: 5/18/2026

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