Project Engineer

Job overview

The Project Engineer role is onsite in Antioch, IL; compensation is not specified. The engineer supports regulated product development in pharmaceutical, medical device, combination-product, or other regulated environments. The role exists to coordinate product development and design-control work while addressing use-related risks and human factors. It contributes by aligning cross-functional teams, maintaining traceable requirements and risk documentation, and managing schedules, risks, and vendor communications through product development.

What you'll do

• Lead planning and coordination of Use-Related Risk Analysis activities
• facilitate collaboration with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams
• document hazards, use scenarios, failure modes, risks, and mitigations
• drive Design Control, Systems Engineering, and Quality by Design activities
• support architecture, requirements, traceability, risk assessments, and change management
• manage project schedules, risks, mitigation plans, and vendor communications.

What we're looking for

Skills & competencies

project engineer

regulated industry

medical device

combination products

human factors

design controls

risk management

antioch il

katalyst healthcares & life sciences

fda 21 cfr part 820.30

iso 14971

Work arrangement

• Weekend coverage required

Why this role

The posting lists a BS with 10 years of relevant experience or an MS with 8 years; five years in regulated industry environments is also specified.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.