Principal R&D Engineer, Electro-Mechanical

This role is in Irvine, California.

What You Will Do

• Lead the design, development, and evaluation of complex electro-mechanical systems, subsystems, and platform-level architectures for medical devices.
• Guide decisions across electrical, mechanical, and integrated system designs while balancing performance, manufacturability, reliability, and cost.
• Lead advanced prototyping, testing, verification, and resolution of complex technical challenges using data-driven analysis.
• Apply advanced engineering principles to solve multidisciplinary problems spanning mechanical, electrical, and system-level domains.
• Partner with clinical stakeholders and cross-functional teams to translate voice-of-customer insights into innovative product solution.
• Drive innovation through invention disclosures, patent development, and the evaluation and integration of emerging technologies.
• Serve as a technical leader and mentor, influencing electrical engineering design initiative across the organization in technical excellence, compliance, and best practices.
• Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, Manufacturing, and Marketing teams to ensure successful product development and commercialization.
• Act as an independent reviewer of engineering documentation and ensure compliance with applicable regulatory and quality requirements.
• Lead initiatives that improve electrical engineering processes, tools, product performance, and organizational capability.

What You Will Need

Required Qualifications

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechatronics Engineering, or a related engineering discipline.
• Minimum eight years of relevant engineering experience in product development.
• Proven experience designing, developing, and optimizing complex electrical/electro-mechanical systems.
• Demonstrated expertise in electrical engineering, with the ability to effectively lead across both disciplines.
• Experience translating user needs into technical requirements, system architectures, and product specifications.
• Strong understanding of system integration, verification, validation, and engineering problem-solving methodologies.
• Experience mentoring engineers and influencing cross-functional technical teams.
• Proficiency with engineering design, analysis, modeling, and testing tools relevant to the candidate's area of expertise.

Preferred Qualifications

• Experience in medical device development or other highly regulated industries.
• Experience with the design and development of catheter-based medical devices, including the integration of electrical, sensing, or electromechanical technologies.
• Advanced knowledge of system integration across electrical and software domains.
• Experience with Design for Manufacturability (DFM), reliability engineering, and systems engineering principles.
• Knowledge of electrical system design, circuit development, testing methods, or controls engineering.
• Knowledge of mechanical design, materials, manufacturing processes, CAD modeling, GD&T, and CAE tools.
• Strong understanding of regulatory requirements, engineering documentation, and quality system compliance. (ex: IEC 60601)
• Ability to communicate complex technical strategies and influence stakeholders across multiple business functions.