Systems Engineer - Electrical

Medical Device Manufacturing & Test Equipment

Work Arrangement: 100% onsite

Pay Rate: $70 per hour

Contract Length: 12 months with possible extension

Applicants must be authorized to work in the United States without visa sponsorship now or in the future. The client cannot consider candidates who require sponsorship.

The Electrical Engineer III will serve as a Systems Engineer with a strong electrical focus, supporting the development of manufacturing and test equipment used in the production and development of medical devices.

This individual will independently or collaboratively develop concepts, specifications, electrical designs, software, test solutions, and equipment for complex manufacturing applications. The role requires close coordination with engineers, designers, technicians, Quality, and other cross-functional partners.

• Lead or participate in project teams responsible for developing complex manufacturing and test equipment.
• Develop clear technical specifications and evaluate the feasibility of proposed equipment and system concepts.
• Provide formal estimates for electrical and software design work.
• Design electrical systems and select appropriate electrical components.
• Develop software and electrical designs using approved departmental tools, procedures, and engineering standards.
• Bridge high-level system architecture with detailed electronic hardware design.
• Identify pneumatic components and automated-control requirements.
• Lead designers, engineers, and technicians through equipment design, assembly, integration, and debugging.
• Coordinate and document project designs, estimates, costs, schedules, and scope changes.
• Complete project deliverables while monitoring schedule, cost, and technical risks.
• Develop and validate test infrastructure used for manufacturing and medical-device development.
• Support hardware-software integration, troubleshooting, and system-level verification.
• Prepare engineering reports, specifications, test documentation, and project-status updates.
• Support FDA and Quality System Regulation requirements by assisting with equipment specifications, qualifications, and validation activities.
• Evaluate and optimize system risk, equipment safety, reliability, and performance.
• Provide training to ensure that equipment and control systems can be operated effectively.
• Promote engineering best practices and continuous process improvement.
• Influence departmental and divisional procedures through cross-functional engineering initiatives.
• Maintain compliance with all applicable quality-system requirements.

• Bachelor’s degree with approximately five to seven years of relevant experience, or
• Master’s degree with approximately three to five years of relevant experience.
• At least five years of applicable electrical, systems, automation, test-equipment, or product-development experience.
• Strong Python programming experience.
• Electronic hardware design experience.
• Hardware-software integration experience.
• Test-infrastructure verification and validation experience.
• Strong analytical and structured problem-solving skills.
• Excellent statistical-analysis capabilities.
• Experience with risk assessment, safety analysis, and system-safety optimization.
• Excellent written and verbal communication skills.
• Strong cross-functional collaboration and project-leadership abilities.
• Previous experience working in a regulated industry.

• Medical-device industry experience.
• Experience developing automated manufacturing or test equipment.
• Experience with FDA-regulated equipment qualification and validation.
• Experience leading multidisciplinary engineering teams.
• Familiarity with pneumatic systems, automation controls, fixtures, and production equipment.

The ideal candidate is a hands-on electrical and systems engineer who can move comfortably between system architecture, electronic hardware design, Python-based software, equipment integration, testing, validation, and troubleshooting. This individual should be capable of leading complex equipment projects from initial concept through build, qualification, and production use.