Project Engineer - Systems Engineering

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. #J-18808-Ljbffr Stark Pharma Solutions Inc