To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL -Anwesha Mohapatra - Collabera | LinkedIn), email your updated resume at Email - anwesha.mohapatra@collabera.com. Thank you!

Pay Range: $55/hr to $60/hr

Job Title: Project Engineer II

Location: North Chicago, IL 60064

Work Type: Onsite

Contract Duration: 12 Months with possible extension

Job Summary:

Seeking a Project Engineer II to support device and combination product development within a highly regulated pharmaceutical environment. The role will focus primarily on Use Related Risk Analysis and broader systems engineering activities throughout the product development lifecycle. This position will collaborate with cross functional teams including human factors, quality, clinical, medical safety, development, and manufacturing. The successful candidate will support Design Controls, risk management, traceability, systems integration, and Design History File activities while ensuring alignment with applicable regulatory and quality requirements.

Key Responsibilities:

• Lead planning and coordination of Use Related Risk Analysis activities across assigned development programs.
• Facilitate cross functional meetings and coordinate technical inputs from human factors, quality, clinical, medical safety, development, and manufacturing teams.
• Support documentation of hazards, use scenarios, use errors, risks, mitigations, and related risk control activities.
• Monitor project milestones and proactively communicate risks, delays, assumptions, and unresolved issues to appropriate stakeholders.
• Support development and review of inspection ready Use Related Risk Analysis documentation.
• Support system architecture, systems integration, user and stakeholder needs, use case analysis, product requirements, and traceability activities.
• Support risk management planning, system risk assessments, Design FMEA, Process FMEA, change management, and configuration management activities.
• Support integration of Design Control and Quality by Design activities throughout product development.
• Coordinate with third party development partners and support deliverable reviews and acceptance activities.
• Maintain project schedules, track project risks, and support development of mitigation plans.

Required Qualifications:

• Bachelor’s degree in Engineering, Science, or a closely related discipline with 5 or more years of relevant experience, or Master’s degree with 3 or more years of relevant experience.
• 3 to 5 years of experience in pharmaceutical, medical device, combination product, or another regulated industry environment.
• Experience with Use Related Risk Analysis, human factors, risk management, or product development.
• Experience with Design History File management and Design Control documentation.
• Knowledge of systems engineering principles including requirements definition, risk management, product architecture, traceability, configuration management, and change management.
• Experience working within regulated product development environments and applicable quality requirements.
• Strong organizational, facilitation, analytical, communication, and decision making skills.

Preferred Qualifications:

• Experience supporting drug product and delivery system development.
• Knowledge of FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, or EU MDR requirements.
• Familiarity with human factors and risk management regulatory expectations.
• Experience with project tracking and document management tools.
• Experience managing third party vendors and supporting deliverable acceptance testing.
• Experience working in a global and highly matrixed environment.

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)