Systems Engineer – Medical Device Risk & Design Controls

Stark Pharma Solutions Inc; Waukegan (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Project Engineer within the Systems Engineering team in R&D in Illinois to support medical device and combination product development.

You will lead URRA activities, assess user workflows, and drive risk management, design controls, and DHF documentation. The role requires strong cross-functional collaboration, knowledge of ISO 14971/13485, and experience with product development in regulated environments.

Qualifications

• Bachelor's or Master's in engineering or related field (Mechanical/Biomedical/Chemical/Science).
• 3–5 years in Medical Device, Pharmaceutical, Biotech, or Combo products (regulated).
• Hands-on URRA or Human Factors risk analysis experience.
• Strong knowledge of Risk Management and FMEA.
• Experience with Design Controls and DHF documentation.
• Knowledge of ISO 14971, ISO 13485, IEC 62366, FDA regs or equivalent.
• Experience with requirements definition, traceability, risk assessment, and change management.
• Strong cross-functional communication and documentation skills.

Responsibilities

• Lead URRA activities and evaluate user workflows and hazards.
• Develop and maintain risk management documentation and DHF artifacts.
• Support FMEA, risk assessments, and mitigation activities.
• Contribute to system architecture, user needs, and product requirements definitions.
• Collaborate with R&D, Quality, Regulatory, Clinical, Manufacturing, and other teams.
• Support product development for combination products and drug delivery devices.
• Ensure regulatory and quality-compliance in development activities.
• Maintain inspection-ready technical documentation and change control.

Skills

URRA & risk analysis

Human Factors

Design Controls

DHF documentation

Regulatory knowledge

Cross-functional communication

Global collaboration

Education

Bachelor's or Master's in Engineering or related field

Tools

FMEA

Job description

Stark Pharma Solutions Inc. is seeking a Project Engineer within the Systems Engineering team in R&D in Illinois to support medical device and combination product development.

You will lead URRA activities, assess user workflows, and drive risk management, design controls, and DHF documentation. The role requires strong cross-functional collaboration, knowledge of ISO 14971/13485, and experience with product development in regulated environments.