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. is a global, multi-platform healthcare solutions manufacturing company. Invested in a broad and ever-growing line of medical technologies, Diversatek manufactures and markets products and solutions for diagnostic and therapeutic gastroenterology procedures, continuing care and rehabilitation, and medical device OEMs. Diversatek owns and operates manufacturing facilities in Wisconsin, Colorado, Brazil, and Vietnam. Our Technical Research and Training Center in Highlands Ranch, Colorado, boasts a best-in-class clinical education and product training center for healthcare providers worldwide.

POSITION SUMMARY

Are you an engineer who thrives on solving complex problems in the medical device industry? Do you often find you are most successful in a work environment that challenges your strong intellectual curiosity? We have an exciting opportunity for an Electrical Engineer who is looking to exercise their problem solving and intellectual curiosity. The successful candidate will participate in the development of products throughout the entire cycle, from inception to technical design, and through commercialization.

ESSENTIAL DUTIES AND 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.

REQUIRED 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.
• 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.

PREFERRED QUALIFICATIONS

• Experience working within a manufacturing environment including familiarity with design and process controls.
• Prior experience in the medical device industry, including FDA, CE Mark, and ISO compliance.
• Experience with designing battery-powered devices and working with low-power wireless protocols such as Bluetooth Low Energy and WiFi.
• Experience with IEC 60601 medical electrical equipment safety standards.
• Experience with flexible circuit design
• Experience developing and supporting PC-based applications for manufacturing verification and test.