Hybrid Electrical Engineer en VERO BIOTECH INC

Description

VERO Biotech is seeking a highly skilled Electrical Engineer to lead all electrical design and sustaining efforts across our GENOSYL® DS console and cassette systems. This role will own electrical schematics, collaborate closely with internal engineering teams, and work directly with our contract design and manufacturing partners to define, develop, and validate electrical solutions for our life-sustaining medical devices.

This position working in both design and test environments, ensuring all designs meet safety, regulatory, and performance requirements as well as able to diagnose electrical issues in the lab, perform troubleshooting and investigations, support verification and validation (V&V) efforts, and write clear technical documentation for regulatory and quality compliance.

• Own all electrical design and sustaining activities for console and cassette systems from concept through production release.
• Lead product investigations for field and manufacturing issues, performing hands-on troubleshooting and root cause analysis.
• Support and execute validation activities, including IEC 60601-1, IEC 60601-1-2, and other safety/performance tests.
• Develop, maintain, and release electrical schematics, wiring diagrams, and PCB documentation.
• Collaborate with contract engineering partners to review, validate, and approve electrical design changes.
• Provide technical input on electrical requirements and design for manufacturability.
• Partner with mechanical, software, and systems engineers to ensure seamless integration of electrical designs.
• Manage electrical BOMs and ensure component selection meets cost, reliability, and manufacturability goals.
• Write and execute test protocols, capture results, and prepare technical reports for regulatory submissions

Qualifications

• Bachelor’s degree in Electrical Engineering or related field; Master’s degree preferred.
• 5+ years of experience in electrical design for complex electro-mechanical systems, preferably in medical devices.
• Strong proficiency in schematic capture and PCB design tools (e.g., Altium, OrCAD).
• Experience collaborating with external design and manufacturing partners.
• Knowledge of medical device development processes, including design controls and risk management.
• Hands-on troubleshooting skills for electrical hardware and troubleshooting experience with low-voltage control circuits, power electronics, and embedded systems.
• Excellent communication, documentation, and cross-functional collaboration skills.

• Knowledgeable of risk management techniques and procedures defined by ISO 14971, FDA guidance, and other international standards
• Familiarity with IEC and FDA medical device requirements.
• Experience with embedded systems, low-voltage control circuits, and power electronics.
• Prior work in combination product development (drug + device) or respiratory products a plus.