Senior Systems Design Engineer – Medical Devices (Mechanical/Mechatronics)

Company Description Systems Ally specializes in providing world-class workforce solutions across medical devices, pharmaceuticals, biotechnology, and IT sectors. Renowned for its expertise in manufacturing excellence, regulatory affairs, innovation, and product development, Systems Ally empowers clients to drive innovation and success in their projects. By offering tailored solutions in staffing, strategic consulting, and training, the company ensures seamless project execution. With a focus on advancing life-saving therapies, Systems Ally supports its partners through innovative work models such as Managed Service Provider (MSP) and Statement of Work (SOW). Role Description The Senior Systems Design Engineer – Medical Devices (Mechanical/Mechatronics) will play a pivotal role in leading system design and integration efforts for cutting-edge medical devices. Day-to-day responsibilities include developing systems architecture, collaborating with cross-functional teams to ensure design feasibility, performing robust engineering analyses, and overseeing the integration of mechanical and electrical components. Additionally, the role involves risk assessment and ensuring compliance with industry standards. This is an on-site contract role located in Chicago, IL. Qualifications Strong expertise in Systems Design and Systems Engineering processesProficiency in System Architecture and designing integrated systemsIn-depth knowledge of Mechanical Engineering concepts, including proficiency in tools such as SolidWorks and GD&TUnderstanding of Electrical Engineering principles and their application in mechatronics and medical devicesExperience working on projects involving medical device development and familiarity with regulatory environments such as ISO 13485 and FDA guidelinesProven problem-solving and analytical skills in a complex engineering environmentBachelor’s or Master’s degree in Mechanical Engineering, Mechatronics, Systems Engineering, or related fieldsPrior experience in product lifecycle management and risk management practices is highly desirable