Director R&D Engineer Medical Device Jobs in Irvine, CA

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.

The Product Development Electrical Engineer plays a critical role in the design and development of new medical devices and sustaining and improvement of electro-mechanical systems for Applied Medical’s devices. This full-time, on-site position offers hands-on experience in a collaborative environment, where you will work closely with cross-functional teams to advance Applied Medical’s products. You will contribute to electrical research and development, schematic and PCB design, system integration, and qualification activities that ensure high-quality devices and components.

Key Responsibilities

• Design and develop electrical systems for medical devices, including schematic generation, PCB layouts, and system integration.
• Create and maintain schematics, wiring diagrams, and technical documentation.
• Perform analog and digital circuit design, including work with high-speed signals, including USB and similar interfaces.
• Support R&D prototyping efforts, including PCB prototyping, testing, troubleshooting, and iteration.
• Manage product development projects from concept through production release.
• Communicate project updates to management and stakeholders.
• Provide engineering support to cross-functional teams (Production, Quality, Regulatory, Clinical, Procurement).
• Perform sustaining engineering, analysis, evaluation, testing, and troubleshooting of electrical systems and components.
• Conduct root-cause analysis and implement corrective actions.
• Develop and update engineering documents such as manufacturing instructions, schematics, drawings, and test methods.
• Qualify new products, components, and electrical systems.
• Write test protocols and reports, collect and analyze data, and ensure compliance with design control procedures and regulatory standards.

Success in This Role Looks Like

• Deliver accurate testing and analysis that supports product development and quality standards.
• Collaborate effectively with cross-functional teams to meet project timelines and objectives.
• Maintain compliance with safety and quality systems throughout all engineering activities.
• Demonstrate strong ownership of electrical design from concept through release.
• Contribute innovative ideas and solutions that improve system performance and reliability.
• Demonstrate adaptability and initiative in learning new technologies and procedures.

This position requires the following skills and attributes

• Bachelor’s degree in Electrical Engineering or Computer Engineering.
• At least three years of engineering experience in electrical design, product development, or R&D.
• Hands-on experience with schematic generation and PCB design using Altium or similar software.
• Experience with analog and digital circuit design, including system-level integration.
• Experience designing low-voltage electrical systems, such as USB, consumer electronics, embedded systems.
• Working knowledge of high-speed signal design and system-level integration.
• Strong troubleshooting skills using lab equipment such as oscilloscopes and signal generators.
• Ability to meet all hospital credentialing requirements, which may include background check, drug screen and vaccinations.
• Demonstrated ability to move designs from concept through prototype to production release.
• Experience working in fast-paced environments where priorities shift and iteration is expected.
• Ability to independently identify issues, propose solutions, and execute.

This position prefers the following skills and attributes

• Experience working in a regulated environment with exposure to FDA requirements and IEC 60601-1 and 60601-1-2 standards.
• Experience with microcontrollers and embedded systems.
• Hands-on prototyping experience in an R&D environment.
• Experience supporting products through production release and sustaining.

• Competitive compensation range: $72000 - $90000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply.

Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

Equal Opportunity Employer

Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates. 

This position requires the following skills and attributes

• Bachelor’s degree in Electrical Engineering or Computer Engineering.
• At least three years of engineering experience in electrical design, product development, or R&D.
• Hands-on experience with schematic generation and PCB design using Altium or similar software.
• Experience with analog and digital circuit design, including system-level integration.
• Experience designing low-voltage electrical systems, such as USB, consumer electronics, embedded systems.
• Working knowledge of high-speed signal design and system-level integration.
• Strong troubleshooting skills using lab equipment such as oscilloscopes and signal generators.
• Ability to meet all hospital credentialing requirements, which may include background check, drug screen and vaccinations.
• Demonstrated ability to move designs from concept through prototype to production release.
• Experience working in fast-paced environments where priorities shift and iteration is expected.
• Ability to independently identify issues, propose solutions, and execute.