Senior Hardware Engineer

GREY STAFFING, LLC
Woodstock, CT, United States
12 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
5 years minimum
Working hours
Regular working hours

Tech stack

Adobe InDesign Altium Designer Bluetooth Low Energy (Bluetooth) Computer Engineering Firmware Failure Mode Effects Analysis Hardware Design Hardware Interface Design Release Management Schematic Capture Test Scripts Hardware Testing
+5 more
21 CFR Part 820 Quality System Regulation Wireless Devices Zigbee Wireless Technologies Pcb Layout

Job description

We are seeking an experienced Senior Hardware Engineer to lead the design and development of electronic hardware for custom foot and hand control systems, primarily supporting medical device applications. This position offers the opportunity to manage hardware development throughout the full product lifecycle, from initial requirements and circuit design through prototyping, testing, verification, production release, and ongoing technical support. The ideal candidate brings at least five years of electronic hardware design experience, with particular expertise in low-power electronics, wireless technologies, and embedded systems. Success in this role requires strong hands-on troubleshooting skills, independent technical judgment, and the ability to collaborate effectively with firmware, mechanical, test, and manufacturing engineering teams., Electronic Hardware Design Design and develop analog, digital, and mixed-signal circuits for embedded control systems. Create schematics, select components, perform design calculations, and develop or oversee PCB layouts. Manage hardware development from concept through production release. Low-Power and Wireless Systems Develop battery-powered and low-power electronic systems, including power management circuits, sensor interfaces, microcontrollers, and wireless communication hardware. Evaluate power consumption, wireless reliability, antenna integration, and overall system performance. Product Development and Integration Collaborate with firmware and mechanical engineers to establish hardware interfaces and integrate electronic assemblies. Troubleshoot system-level challenges and contribute to technical discussions with customers and suppliers. Prototyping, Testing, and Verification Support prototype development, hardware evaluation, and design refinement. Diagnose circuit performance issues, component failures, and hardware/firmware interactions. Establish hardware acceptance criteria and collaborate with test engineering to develop and execute verification plans. Analyze test results, resolve failures, and document compliance with design requirements. Documentation and Risk Management Develop and maintain hardware specifications, schematics, bills of materials, design analyses, test reports, and engineering change documentation. Participate in design reviews and Failure Mode and Effects Analyses (FMEA) to address safety, reliability, and performance. Manufacturing and Technical Support Support the transition of new designs into manufacturing. Resolve production and field issues, including component substitutions and obsolescence. Provide technical guidance to test engineers and engineering technicians.

Requirements

Bachelor’s degree in Electrical Engineering, Computer Engineering, or a related field, or an equivalent combination of education and relevant experience. Minimum of five years of electronic hardware design and development experience, including ownership of projects from concept through production. Strong expertise in analog and digital circuit design, embedded microcontroller hardware, component selection, schematic capture, and PCB design. Hands-on experience developing low-power and battery-operated electronic systems, including wireless hardware integration. Proficiency troubleshooting electronic circuits using oscilloscopes, multimeters, logic analyzers, and other laboratory equipment. Strong technical documentation, analytical, and problem-solving abilities. Ability to independently manage development activities while collaborating across engineering disciplines. Preferred Qualifications Experience designing medical devices, medical device accessories, or electronic products for regulated medical environments. Familiarity with FDA 21 CFR Part 820, the Quality Management System Regulation (QMSR), and ISO 13485, including design controls, verification, validation, risk management, and documentation. Proficiency with Altium Designer for schematic capture, PCB layout, and design documentation. Experience with Hall effect sensors and magnetic sensing technologies, including sensor positioning, magnet selection, air-gap tolerances, and performance evaluation. Knowledge of hardware testing methodologies, including functional, environmental, reliability, and fault testing. Experience developing test protocols, establishing acceptance criteria, and selecting appropriate test samples. Familiarity with wireless technologies such as Bluetooth Low Energy (BLE) and Zigbee. Understanding of electrical safety, electromagnetic compatibility (EMC), and wireless regulatory compliance testing., A hands-on hardware engineer who enjoys taking ownership of complex electronic designs, solving technical challenges, and bringing reliable products from concept to production. Experience with low-power wireless systems and medical device development is particularly valuable.

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