Staff Electrical Engineer (Hardware focus)

NuevoSono, a T45 Labs portfolio company is seeking a Staff-level Electrical Hardware Engineer to join our innovative team developing Intravascular Ultrasound (IVUS) systems. The ideal candidate will have hands-on experience in electrical hardware design for medical devices, a solid understanding of FDA submission processes, and a demonstrated ability to translate clinical and regulatory requirements into robust product designs. This role is critical to ensuring our products meet the highest standards of safety, performance, and regulatory compliance.

Responsibilities

• Lead the design, development, and validation of analog, digital, and mixed-signal circuits for IVUS systems, including embedded systems, sensors, and power management components.
• Own schematic capture, PCB layout, and prototype bring-up using industry-standard tools (e.g., Altium).
• Develop and document electrical design specifications, test methods, and manufacturing instructions in compliance with quality system requirements.
• Drive design verification and validation activities, ensuring compliance with IEC 60601, ISO 13485, and FDA 21 CFR Part 820 standards.
• Prepare and maintain technical documentation to support regulatory submissions (FIH, 510(k), PMA), including risk analysis, design history files, and product labeling.
• Support Electromagnetic Compatibility (EMC) and safety certification testing, and participate in risk management and root cause analysis for product failures.
• Collaborate cross-functionally with mechanical, software, clinical, and quality teams to ensure system-level integration and alignment with user and regulatory requirements.
• Participate in sustaining engineering and continuous improvement initiatives for existing products.
• Act as a subject matter expert on electrical issues, providing technical leadership and mentoring to junior engineers.

Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering or a related field.
• 5+ years of experience in electrical hardware development, with a focus on medical devices (IVUS or intravascular catheters preferred).
• Proven track record in successful FDA submissions (510(k) and/or PMA), including preparation of technical documentation and participation in regulatory audits.
• Strong knowledge of analog/digital circuit design, PCB layout, and electrical design verification.
• Familiarity with medical device standards (IEC 60601, ISO 14971, ISO 13485) and quality systems.
• Experience with EMC/EMI design principles and compliance testing.
• Excellent problem-solving, communication, and documentation skills.
• Ability to work independently and collaboratively in a fast-paced, regulated environment.

Location and Compensation

This is an onsite position, based in our Santa Clara, CA office.

T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.

The anticipated salary range for this position is $149,000 - $201,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as experience, and skills.

Equal Employment Opportunity Statement

T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs.

We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.

Third-Party Recruiter Notice

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email [email protected].