Project Engineer

Creative Solutions Services, LLC; Antioch (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Project Engineer with a strong background in pharmaceutical, medical device, combination products, or other regulated industries. The role involves leading cross-functional teams and driving design control and risk management from concept through market release.

The ideal candidate has 10+ years in regulated environments and expertise in DHF management, URRA, human factors, and regulatory standards such as FDA 21 CFR Part 820 and ISO

Qualifications

• 10+ years of relevant experience in regulated environments.
• Experience with Design History File (DHF) management and Design Control.
• Experience with Use-Related Risk Analysis (URRA), Human Factors, and Risk Management.
• Knowledge of FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred

Responsibilities

• 5+ years of experience in regulated industry environments (Pharma / Medical Device / Combination Products)
• Lead planning and coordination of Use-Related Risk Analysis activities
• Facilitate cross-functional collaboration with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams
• Support documentation of hazards, use scenarios, failure modes, risks, and mitigations
• Drive Design Control, Systems Engineering, and Quality by Design (QbD) activities
• Support system architecture, requirements definition, traceability, risk assessments, and change management
• Manage project schedules, risks, mitigation plans, and vendor communications

Skills

Project coordination

Communication

Facilitation

Stakeholder management

Regulatory requirements knowledge

Education

BS in Engineering/Science

MS in Engineering/Related field

Job description

Summary:

We are looking for an experienced Project Engineer with a strong background in pharmaceutical, medical device, combination products, or other regulated industries.

Roles & Responsibilities:

• 5+ years of experience in regulated industry environments (Pharma / Medical Device / Combination Products)


• Strong expertise in Design History File (DHF) management and Design Control documentation


• Experience with Use-Related Risk Analysis (URRA), Human Factors, and Risk Management


• Knowledge of FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred


• Experience supporting end-to-end product development from concept through market release


• Strong project coordination, communication, facilitation, and stakeholder management skills


• Lead planning and coordination of Use-Related Risk Analysis activities


• Facilitate cross-functional collaboration with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams


• Support documentation of hazards, use scenarios, failure modes, risks, and mitigations


• Drive Design Control, Systems Engineering, and Quality by Design (QbD) activities


• Support system architecture, requirements definition, traceability, risk assessments, and change management


• Manage project schedules, risks, mitigation plans, and vendor communications

Education & Experience:

• BS in Engineering, Science, or related discipline with 10+ years of relevant experience


• MS with 8+ years of relevant experience


• Ideal candidates will have experience with drug product delivery systems, combination products, human factors engineering, and regulated product development.