R&D System Project Engineer; Combination Products​/Medical Devices

Position Title: R&D System Project Engineer (Combination Products/Medical Devices)

Location:
North Chicago, IL 60064

Contract Period: 12 Months / 1 Year

Shift Timings:
Mon - Fri, 08:00 AM - 05:00 PM CST

Location:
This position is based in Lake County, IL. The role is part of a global team and requires regular collaboration with colleagues in France and the United State

Contract: 1 year - based on performance and business needs

Local candidates preferred here you guys as onsite for 2nd rounds is now a requirement.

Please make sure they are able to make for onsite interview within a reasonable time (1 week or so)

• We are seeking a Project Engineer to join the Systems Engineering team within R&D (Device & Combination Products Development). This role primarily supports use-related risk analysis (Human Factors & Risk Management) and contributes to broader systems engineering activities.
• This is a highly collaborative, cross-functional role where the engineer will represent systems engineering in product development teams, focusing on patient safety, user interaction, and design control compliance.

• Perform use-related risk analysis (URRA) by evaluating user workflows, identifying potential user errors, and assessing patient risk
• Develop and maintain risk management documentation aligned with regulatory standards
• Create and manage Design Control documents within the Design History File (DHF)
• Collaborate with cross-functional teams (R&D, design, quality, regulatory)
• Facilitate discussions on best practices, risk alignment, and design improvements
• Support development of combination products (drug-device systems)
• 3–5 years of experience in Medical Devices, Pharmaceutical / Biotech, Combination Products or Other regulated industries
• Hands‑on experience with Risk analysis (FMEA, URRA, etc.)
• Experience with Design validation vs. process validation (clear understanding required)
• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Or related engineering field
• Systems Engineer in Medical Devices or Combination Products
• Product Development Engineer with design control + risk management exposure
• Experience working on drug delivery devices or patient-use products
• Experience with API / drug formulation
• 8 to 10 years of experince can be overqualified
• Relocation candidates will work (but want strong reason)

• Use-Related Risk Analysis / Human Factors Engineering
• Risk Management Knowledge (ISO standards, patient safety focus)
• Design Control & DHF Documentation Experience
• Strong communication and cross‑functional collaboration skills
• Experience in regulated environments (medical device, pharma, or combination products)

• Background in mechanical or drug delivery devices
• Experience with combination products (device + drug)
• Exposure to human factors engineering standards
• Knowledge of product development lifecycle in R&D
• Familiarity with global regulatory standards (FDA, ISO 14971, IEC 62366)

• Working knowledge of use-related risk analysis, human factors, risk management, or product development preferred
• 3–5 years of experience in pharmaceutical, medical device, combination product, or other regulated industry environments.
• Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
• Strong organizational, facilitation, and communication skills.
• Familiarity with relevant human factors and risk management expectations.

Client is seeking a Systems Engineer to join their Device and Combination Product Development team within R&D. This individual will contribute to the development of innovative devices and therapeutic combination products…