Senior Medical Device Electrical Engineer

Diversatek Healthcare; Highlands Ranch (CO); On-site; USD 85,000 - 120,000; Full time

Job summary

Diversatek, Inc. in Highlands Ranch, CO is seeking an Electrical Engineer to design, develop, test, and support hardware and firmware for next-generation medical diagnostic products.

You will contribute to production support and issue resolution throughout the product lifecycle. You will collaborate with manufacturing, quality, regulatory, and other engineering teams to ensure continuity of design and requirements while ensuring compliance with IEC, FDA, CE, MDSAP, and ISO standards in a

Qualifications

• B.S. in Electrical Engineering or equivalent.
• 5–10 years of relevant industry experience as an Electrical Engineer.
• Experience designing, programming, testing, and supporting microcontroller-based systems, including hardware and firmware.
• Strong circuit design and troubleshooting skills.
• Proficiency with PCB layout CAD tools such as Altium, Allegro, OrCAD, or equivalent.
• Strong technical writing skills and experience generating formal engineering documentation.
• Excellent verbal and written communication skills.
• Ability to work effectively in a team environment.

Responsibilities

• 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 root cause analysis, and implement corrective actions.
• Lead or support product verification and validation activities required to qualify and release medical diagnostic devices.
• Lead the transition from engineering development to production, including creation of design documentation, test procedures, and production fixturing.
• Develop and support automated production test hardware and software.
• Collaborate cross-functionally with manufacturing, quality, regulatory, and other engineering teams to ensure continuity of design and requirements.
• Perform failure analysis investigations and recommend design or process improvements
• Ensure product development and sustaining activities comply with IEC, FDA, CE, MDSAP, ISO, and other requirements.
• Create and maintain technical documentation including schematics, drawings, specifications, test protocols, risk management files, engineering change orders, and regulatory submissions.
• Perform other engineering-related tasks as required.

Skills

Electrical design

Firmware development

PCB layout

Troubleshooting

Technical writing

Cross-functional teamwork

Education

Bachelor's degree in Electrical Engineering

Tools

Altium

OrCAD

Allegro

Job description

Diversatek, Inc. in Highlands Ranch, CO is seeking an Electrical Engineer to design, develop, test, and support hardware and firmware for next-generation medical diagnostic products.

You will contribute to production support and issue resolution throughout the product lifecycle. You will collaborate with manufacturing, quality, regulatory, and other engineering teams to ensure continuity of design and requirements while ensuring compliance with IEC, FDA, CE, MDSAP, and ISO standards in a