Medical Device Electrical Engineer – Hardware & Firmware

Diversatek Healthcare, Inc.; Highlands Ranch (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Diversatek Healthcare, Inc. in Highlands Ranch, Colorado, is seeking an Electrical Engineer to solve complex problems in medical device development. You will participate from inception to design and through commercialization, applying your hardware and firmware skills to real-world diagnostic products.

You will design and test electronics, support production, and collaborate with cross-functional teams to meet IEC, FDA, CE, ISO requirements while creating thorough design documentation.

Qualifications

• ; BS in Electrical Engineering or equivalent.
• 5–10 years relevant industry experience as an Electrical Engineer.
• Experience designing, programming, testing, and supporting microcontroller-based systems.
• 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.
• Proficient with Microsoft Word and Excel.
• Excellent verbal and written communication skills.
• Strong problem-solving, analytical, organizational, and decision-making abilities.
• High attention to detail appropriate for medical device development.
• Ability to work effectively in a team environment and interact with all levels of the organization.

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

CAD tools

Technical writing

MS Word/Excel

Team collaboration

Diagnostics troubleshooting

Medical device experience

Education

B.S. in Electrical Engineering

Tools

Altium

OrCAD

Allegro

Regulatory documentation

Job description

Diversatek Healthcare, Inc. in Highlands Ranch, Colorado, is seeking an Electrical Engineer to solve complex problems in medical device development. You will participate from inception to design and through commercialization, applying your hardware and firmware skills to real-world diagnostic products.

You will design and test electronics, support production, and collaborate with cross-functional teams to meet IEC, FDA, CE, ISO requirements while creating thorough design documentation.