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: Hybrid

Contract Duration: 12 months with possible extension

Job Summary:

The Project Engineer II will support systems engineering and combination product development activities within a regulated pharmaceutical environment. This role will primarily focus on Use Related Risk Analysis and broader Design Control activities across drug delivery systems and medical device programs. The engineer will collaborate with human factors, quality, clinical, safety, development, manufacturing, and other cross functional teams to ensure safe and effective product development. The position requires strong technical documentation, facilitation, organization, risk management, and communication capabilities.

Key Responsibilities:

• Lead planning and coordination of Use Related Risk Analysis activities across assigned development programs.
• Facilitate cross functional meetings and coordinate timely technical inputs from relevant stakeholders.
• Support identification and documentation of hazards, use scenarios, use errors, risks, mitigations, and related product requirements.
• Coordinate systems engineering activities including user needs, stakeholder needs, requirements definition, system architecture, integration, traceability, and change management.
• Support risk management activities including Use Related Risk Analysis, Design FMEA,
• Process FMEA, and system risk assessments.
• Maintain Design History File architecture and support development of Design Control documentation in accordance with applicable regulations.
• Monitor project milestones, identify risks and delays, and escalate unresolved issues to appropriate stakeholders.
• Support third party development activities including communication, deliverable review, acceptance testing, and coordination.
• Contribute to process improvement initiatives and promote consistency in risk analysis and Design Control execution.
• Develop project schedules, track deliverables, and communicate status across a matrixed organization.

Required Qualifications:

• Bachelor degree in Engineering, Science, or closely related discipline with at least 5 years of relevant experience, or Master degree with at least 3 years of relevant experience.
• Three to five years of experience in pharmaceutical, medical device, combination product, or another regulated industry environment.
• Demonstrated experience with systems engineering principles, Design Controls, risk management, requirements definition, traceability, and change management.
• Strong experience with Design History File management and creation of Design Control documentation.
• Working knowledge of Use Related Risk Analysis, human factors, and risk management methodologies.
• Strong organizational, facilitation, analytical, scientific writing, and verbal communication skills.
• Experience managing project schedules, project risks, mitigation plans, and competing priorities.
• Proficiency with project tracking and document management tools.

Preferred Qualifications:

• Experience supporting drug product and delivery system development.
• Familiarity with human factors and risk management regulatory expectations.
• Knowledge of FDA medical device regulations, ISO 14971, ISO 13485, and EU MDR requirements.
• Experience with electromechanical pumps, autoinjectors, prefilled syringes, on body devices, or other complex delivery systems.
• Experience interfacing with third party vendors and managing deliverable acceptance activities.
• Ability to synthesize complex technical information into clear plans and documentation.

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)