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Project Engineer Medical Device Jobs in Illinois

... days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance ... Participate in project planning, design reviews and risk assessments using formal risk analysis ...

Project Engineer III - Drug Delivery Location: Linden Road, Rockford, IL 61109 Shift: 1st Shift ... or medical device packaging equipment. • Certifications in cGMP, LEED, OSHA, or related ...

Project Engineer III - Drug Delivery Location: Linden Road, Rockford, IL 61109 Shift: 1st Shift ... Familiarity with combination products or medical device packaging equipment. Certifications in cGMP ...

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Showing results 1-20

Project Engineer Medical Device information

See Illinois salary details

$43.6K

$87.8K

$131.8K

How much do project engineer medical device jobs pay per year?

As of Aug 21, 2026, the average yearly pay for project engineer medical device in Illinois is $87,836.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,700.00 and $100,300.00 per year, depending on experience, location, and employer.

What does a project engineer do in the medical device industry?

A Project Engineer in the medical device industry is responsible for planning, coordinating, and managing projects related to the development and manufacturing of medical devices. They oversee project timelines, budgets, and resources, ensuring that all technical and regulatory requirements are met. Their work involves collaborating with cross-functional teams, such as design, quality assurance, and regulatory affairs, to bring safe and effective medical devices to market. Project Engineers also help resolve technical challenges and ensure products comply with industry standards and government regulations.

What are the key skills and qualifications needed to thrive as a project engineer in the medical device industry?

To excel as a Project Engineer in medical devices, you need a solid background in engineering (typically a degree in biomedical, mechanical, or electrical engineering), experience with product development, and knowledge of regulatory standards like FDA and ISO 13485. Familiarity with CAD software, project management tools, and validation protocols is highly valuable, along with certifications such as PMP or Six Sigma. Strong problem-solving abilities, collaboration, and effective communication are essential soft skills for leading cross-functional teams and resolving technical challenges. These skills and qualifications ensure safe, compliant, and innovative device development that meets patient and market needs.

How does a project engineer in the medical device industry typically collaborate with cross-functional teams during product development?

As a Project Engineer in the medical device field, you’ll work closely with cross-functional teams such as R&D, quality assurance, regulatory affairs, and manufacturing. Collaboration involves coordinating project timelines, ensuring design requirements are met, and facilitating communication between departments to address technical challenges and regulatory compliance. Regular meetings and clear documentation are essential to keep all stakeholders aligned, and you may often serve as a bridge between engineering and non-engineering teams. This collaborative environment fosters innovation and helps ensure the successful and timely launch of safe, effective medical devices.

What is the difference between Project Engineer Medical Device vs Quality Engineer Medical Device?

AspectProject Engineer Medical DeviceQuality Engineer Medical Device
Required CredentialsBachelor's in Engineering, certifications like PMP beneficialBachelor's in Engineering or Science, certifications like CQE preferred
Work EnvironmentDesign, development, and project management teams in manufacturing or R&DQuality assurance, compliance, and inspection teams in manufacturing
Employer & Industry UsageMedical device companies focusing on product development and project executionMedical device companies ensuring product quality and regulatory compliance
Common Search & Comparison IntentUnderstanding project management roles in medical device industryUnderstanding quality assurance roles in medical device industry

The Project Engineer Medical Device focuses on managing product development projects, coordinating teams, and ensuring timely delivery. In contrast, the Quality Engineer Medical Device concentrates on maintaining product quality, compliance with regulations, and conducting inspections. Both roles are essential in medical device companies but serve different functions within the product lifecycle.

Infographic showing various Project Engineer Medical Device job openings in Illinois as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 12% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $87,836 per year, or $42.2 per hour.

Project Engineer

Stark Pharma Solutions Inc

North Chicago, IL • On-site

Contractor

Posted 15 days ago


Job description

Position: Project Engineer
Location: Illinois
Duration: Long Term

Job Overview

We are seeking an experienced Project Engineer to support medical device and combination product development projects. The ideal candidate will lead Use-Related Risk Analysis (URRA), Systems Engineering, and Design Control activities while collaborating with cross-functional teams to ensure successful product development and regulatory compliance.

Key Responsibilities

  • Lead and coordinate Use-Related Risk Analysis (URRA) activities across multiple projects.
  • Facilitate cross-functional meetings to develop and maintain risk management documentation.
  • Collaborate with Human Factors, Quality, Clinical, Manufacturing, and Engineering teams to identify hazards, risks, and mitigation strategies.
  • Develop and maintain Design History Files (DHF) and Design Control documentation.
  • Support Systems Engineering activities, including requirements management, traceability, system architecture, and risk assessments.
  • Perform and review Use-Related Risk Assessments, Design FMEAs, and Process FMEAs.
  • Monitor project schedules, milestones, risks, and deliverables while communicating project status to stakeholders.
  • Support change management, third-party vendor coordination, and Quality by Design (QbD) activities.
  • Ensure compliance with FDA regulations, ISO standards, and medical device quality requirements.

Required Qualifications

  • BS in Engineering, Science, or a related discipline with 10+ years of experience, or MS with 8+ years of relevant experience.
  • 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industries.
  • Expertise in Design History File (DHF) management and Design Control documentation.
  • Strong knowledge of Systems Engineering, product development, requirements management, and traceability.
  • Experience with Use-Related Risk Analysis (URRA), Human Factors Engineering, Risk Management, Design FMEA, and Process FMEA.
  • Familiarity with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR.
  • Experience with project scheduling, document management tools, and vendor management.
  • Excellent analytical, organizational, communication, and cross-functional collaboration skills.