Electrical Engineer

Job Title:

Electrical Engineer – Medical Diagnostic Products Job Description

This role focuses on designing, developing, testing, and sustaining hardware and firmware for next‑generation medical diagnostic products. You will support existing product lines, lead troubleshooting and failure analysis, and ensure products meet stringent regulatory and quality standards in a regulated medical device environment.

• Design, develop, test, and support hardware and firmware for next‑generation medical diagnostic products.
• Provide engineering production support for existing medical diagnostic product lines.
• Troubleshoot complex production and field issues, perform detailed root cause analysis, and implement effective corrective actions.
• Lead or support product verification and validation activities required to qualify and release medical diagnostic products.
• Support the transition from engineering development to production, including creating design documentation, test procedures, and production fixturing.
• Develop and support automated production test hardware and software to improve reliability and efficiency.
• Collaborate cross‑functionally with manufacturing, quality, regulatory, and other engineering teams to ensure continuity of design and adherence to requirements.
• Perform failure analysis investigations and recommend design or process improvements to enhance product performance and reliability.
• Ensure product development and sustaining engineering activities comply with IEC, FDA, MDSAP, and other applicable regulatory and industry requirements.
• Create and maintain comprehensive technical documentation including schematics, drawings, specifications, test protocols, risk management files, engineering change orders, and regulatory submission materials.
• Perform other engineering‑related tasks as needed to support product development and production operations.

• Bachelor of Science degree in Electrical Engineering or equivalent technical discipline.
• 5–10 years of relevant industry experience as an Electrical Engineer.
• Hands‑on experience designing, programming, testing, and supporting microcontroller‑based systems, including both hardware and firmware.
• Strong circuit design skills, including analog and digital design for complex electronic systems.
• Demonstrated ability to troubleshoot electronic circuits and systems in both development and production environments.
• Proficiency with PCB layout CAD tools such as Altium, Allegro, or equivalent platforms.
• Experience working with firmware for embedded or microcontroller‑based systems.
• Experience in medical device or other regulated environments, with familiarity in complying with standards such as IEC, FDA, and MDSAP.

• Experience with PCB design from concept through layout, fabrication, and test.
• Background in supporting automated production test hardware and software.
• Ability to create clear and accurate engineering documentation, including schematics, drawings, specifications, and test procedures.
• Experience contributing to risk management files and engineering change orders in a regulated setting.
• Understanding of regulatory submission processes for medical or similarly regulated products.
• Strong cross‑functional collaboration skills, with the ability to work closely with manufacturing, quality, regulatory, and other engineering teams.
• Experience with medical diagnostic products or broader medical device development is highly beneficial.

You will work in a small, highly collaborative engineering team in a regulated medical device manufacturing environment. The role is fully onsite, five days per week, providing direct access to development labs, production areas, and test equipment. The setting…