Systems Engineer

• Design, develop, and integrate complex electromechanical systems for medical devices.
• Collaborate with cross-functional teams including electronics hardware, mechanical components, software/firmware, and quality engineers to ensure seamless system integration.
• Conduct system-level analysis, including requirements gathering, architecture design, and risk management in compliance with ISO 14971.
• Perform detailed design tasks, including the development of mechanical components and assemblies using tools such as SolidWorks.
• Analyze system performance and reliability through simulations, testing, and verification efforts.
• Support the development and execution of verification and validation plans.
• Prepare technical documentation including system requirements, design specifications, test protocols and test reports.
• Work with the quality team to ensure compliance with ISO 13485, IEC 60601, and IEC 62304 standards, among others.

• Bachelor’s degree in Mechanical, Electrical, or Systems Engineering (Master’s or PhD degree preferred).
• 10+ years of experience in systems engineering within a regulated industry (medical device experience preferred).
• Proficiency with systems engineering tools and methodologies, including requirements management and risk analysis.
• Solid understanding of electromechanical systems and design tools such as SolidWorks.
• Familiarity with IEC 62304 and ISO 13485 standards for medical devices.
• Experience in design for manufacturing (DFM), design for assembly (DFA), and working with engineering drawings per ASME Y14.5.
• Strong experience with design verification, validation, and compliance to industry standards (UL, FCC, IEC 60601).

Preferred Skills and Experience:

• Experience with embedded firmware, hardware-software integration, and medical device safety standards (e.g., IEC 60601-1, 60601-1-2).
• Strong analytical skills for mechanical and electromechanical system designs, including stress analysis, thermal management, and safety evaluations.
• Hands-on experience with prototyping, testing, and debugging of complex

Physical

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

DesignPlex Biomedical specializes in the design, development, and contract manufacturing of cutting-edge medical devices. Since our founding in 2015, we’ve worked on devices such as implanted blood pumps, artificial hearts, neuromodulation, and other innovative medical technologies. Our work is driven by a commitment to quality, and we are ISO 13485:2016 certified for contract design and manufacturing including AIMD. We are expanding our team as we continue to push boundaries in medical device development.

Join a dynamic, entrepreneurial organization where you’ll contribute to life-changing medical technologies and enjoy working with a team that values integrity, work-life balance, and innovation.