Project Engineer – Systems Engineering

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Project Engineer Systems Engineering

Location: Illinois

Duration: Long Term

Job Overview

We are seeking a Project Engineer to join the Systems Engineering team within R&D, supporting Medical Device and Combination Product Development. The role will primarily focus on Use-Related Risk Analysis (URRA), Human Factors, Risk Management, Design Controls, and Design History File (DHF) documentation.

The ideal candidate will have experience working in medical device, pharmaceutical, biotech, or combination product environments and possess strong knowledge of product development, risk management, and design control processes.

Key Responsibilities

• Lead and coordinate Use-Related Risk Analysis (URRA) activities.
• Evaluate user workflows, use scenarios, potential use errors, hazards, and patient risks.
• Develop and maintain risk management documentation.
• Support FMEA, risk assessments, and risk mitigation activities.
• Create and maintain Design Control documentation within the DHF.
• Support design inputs, requirements, traceability, and systems integration activities.
• Participate in system architecture, user needs, use case analysis, and product requirements definition.
• Collaborate with R&D, Human Factors, Quality, Regulatory, Clinical, Manufacturing, and other cross-functional teams.
• Support combination product and drug delivery device development.
• Ensure compliance with applicable regulatory and quality requirements.
• Support design validation, risk management, and product development activities.
• Facilitate cross-functional meetings and drive completion of project deliverables.
• Support change management and integration of third-party development activities.
• Identify project risks, track milestones, and support mitigation activities.
• Maintain clear and inspection-ready technical documentation.

Required Qualifications

• Bachelor s or Master s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Science, or a related field.
• 3 5 years of experience in Medical Device, Pharmaceutical, Biotech, Combination Products, or another regulated industry.
• Hands-on experience with Use-Related Risk Analysis (URRA), Human Factors, or similar risk analysis activities.
• Strong knowledge of Risk Management and FMEA.
• Experience with Design Controls and Design History File (DHF) documentation.
• Knowledge of ISO 14971, ISO 13485, IEC 62366, FDA regulations, or other applicable regulatory standards.
• Experience with product development and systems engineering principles.
• Understanding of design validation versus process validation.
• Experience with requirements definition, traceability, risk assessment, and change management.
• Strong cross-functional communication, facilitation, organizational, and documentation skills.
• Experience working in a regulated R&D or product development environment.
• Ability to work effectively with global and cross-functional teams.

Preferred Qualifications

• Experience with combination products or drug delivery devices.
• Experience with pre-filled syringes, autoinjectors, on-body delivery systems, mixing devices, or electromechanical pumps.
• Experience with Human Factors Engineering and patient-use products.
• Knowledge of FDA 21 CFR Part 820.30, 21 CFR Part 4, and EU MDR.
• Experience supporting products from concept through commercialization.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.