Electrical Engineer II

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, ISO
  13485, ISO 14708-1/-5)
• Advanced use of…