Electrical Hardware Engineer - IVUS Company

Title: Electrical Hardware Engineer

Status: Full-time, Exempt

Reports to:

Position Overview
We   are   seeking   a   well-rounded   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.

Key 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.

Key Attributes

• Innovative thinker with strong attention to detail and a commitment to quality.
• Proactive, adaptable, and comfortable wearing multiple hats in a small team environment.
• Strong leadership and mentoring abilities.

Location and Compensation

This is an on-site 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.

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.