Electrical Engineer II

BiVACOR Inc.; Huntington Beach (CA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical Benefits

Dental/Vision

401(k) matching

Generous vacation policy

Job summary

A leading medical device company in Huntington Beach is looking for an Electrical Engineer to support the design and testing of an implantable artificial heart. This role involves developing specifications, conducting experiments, and ensuring compliance with industry standards. Ideal candidates will have a Bachelor’s degree in Electrical Engineering and at least 2 years of relevant experience, particularly with medical devices. The position offers competitive benefits and a collaborative work environment.

Qualifications

• Minimum of 2 years' experience in design and testing.
• Implementation of electrical engineering principles for medical devices.
• Working knowledge of Electromagnetic Compatibility standards.

Responsibilities

• Support engineering design and verification of electrical subsystems.
• Develop test procedures for components and systems.
• Document test results and ensure compliance with specifications.

Skills

Design and prototyping of electronic circuits

Testing of electrical subsystems

Project management

Team collaboration

Education

Bachelor’s degree in electrical engineering

Tools

Spectrum analyzers

Oscilloscopes

Multimeters

Job description

The Electrical Engineer (EE) will be an integral member of the BiVACOR engineering team, supporting design, verification, and validation efforts of the BiVACOR implantable artificial heart, with a focus on the external patient controller and peripheral subsystems. The EE will utilize technical expertise to assist in developing system specifications and test methods, and to perform component, integration, and system tests of the BiVACOR device. With a clear technical vision, the EE is required to support the development of all electrical systems for the BiVACOR implantable artificial heart.
This position requires the ability to plan, conduct, and document experiments to verify and validate the device design, ensuring the device reliably and repeatedly meets the design input specification. Working closely with management and internal company engineers, the electrical engineer will ensure the long-term value and viability of products.

For the Huntington Beach (CA) location, BiVACOR is seeking motivated, flexible team members eager to contribute to this active, dynamic project. This role requires creativity and flexibility to find the best solutions in a multidisciplinary, dynamic R&D environment. Strong initiative in a team environment, organizational, time/project management, and technical skills are required.

KEY RESPONSIBILITIES

• Support the engineering design, analysis, and verification of all electrical subsystems, including:
  • Motor and Magnetic bearing
  • Percutaneous lead
  • Controller
  • Peripherals (Batteries, Console, Power Supplies)
• Support the specification of component and system test requirements for the external patient controller subsystem.
  • Analyse product and software design input specifications in cooperation with team members from electrical, mechanical, and software engineering.
  • Contribute to the development of feasibility plans and sets of verification and validation tests that meet design input requirements and risk control measure implementation.
• Design and development of efficient test procedures in accordance with defined specifications.
  • Execute test procedures and test cases to verify the performance of components and systems.
  • Create justifications for all test acceptance criteria.
  • Support the development of specialized tooling or fixturing for testing.
  • Define and justify test sample size(s), test conditions, and test apparatus.
  • Review test protocols and reports from third-party testing facilities.
  • Contribute to work instruction documentation that describes the testing procedures.
  • Application of interdisciplinary technical standards, principles, theories, concepts, and techniques.
• Conduct and report experiments to verify and validate the product input specifications.
  • Manage and ensure appropriate certifications for test equipment.
  • Verify test coverage and consistency of devised testing procedures.
• Feedback into the development, manufacturing, and support divisions of BiVACOR
  • Coordinate the development of specific test software required to verify design input requirements with the software development team.
  • Participate in and drive risk analysis and corrective action activities (e.g., design failure mode and effect analysis; hazard analysis).
• Create documentation (specifications, design documents, protocols, procedures, work instructions) adhering to quality procedures, regulations, standards, and industry best practices under Design Control for regulatory submissions to the FDA.

REQUIREMENTS – QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in electrical engineering or equivalent.
• Experienced in design, prototyping, and testing of electronic circuits, components, and subsystems – min. 2 years.
• Practical implementation of electrical engineering principles for medical devices.
• Experience with the development of digital and analog electronic devices.
• Working knowledge requirements, design principles, and test procedures for Electromagnetic Compatibility and Immunity.
• Understanding of the development lifecycle and design controls for Class II/II medical devices
• Understanding and application of applicable standards (IEC 60601-1 and collaterals, ISO 14971, IEC 62304, ISO13485, ISO 14708-1/-5)
• Advanced use of electronic equipment such as spectrum analyzers, oscilloscopes, and multi-meters.

BiVACOR ® is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution.

Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia. Our highly driven and performing team has complementary science and business minds to focus on “Replacing Hearts and Restoring Lives.”

Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us.

BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email [e-mail] .

Our Benefits and Perks

Health and Welfare

• Medical Benefits – Numerous HMO and PPO options, several of which have monthly premiums fully employer funded.
• Dental/Vision, Short-term & Long-term Disability also available at low employee cost.

Vacation and PTO

BiVACOR also has very generous vacation and PTO policies. Vacation policy for first year employees is 80 hours per year. Increasing yearly up to 136 hours upon 7th year of employment. In addition to vacation, we also have a PTO policy equaling an additional 80 hours of time off per year.

401(k)

BiVACOR proudly offers both Non-Elective and Elective 401(k) plans.

Our Non-Elective 401(k) is a 4% employer only contribution, made on your behalf each pay period and immediately vested upon 90-day qualification.

Our Elective 401(k)-employer match is up to 6%. That means that for every dollar you contribute to your 401 (k), you will receive a matching dollar-for-dollar contribution in your account up to 6% of your pay.

Incentives

Short-Term and Long-Term Incentives are also part of our current benefit package.