Electrical Engineer III

The Electrical Engineer (EE) will be an integral member of our client's engineering team, support design, verification and validation efforts of our client's cardiovascular implantable, with a focus on the external patient controller and peripheral subsystems. The EE will utilize technical ability to assist in developing system specifications, test methods and perform component, integration and system tests of our client's device. With a clear technical vision, the EE is required to support the development of all electrical systems for our client's cardiovascular implantable.

This position requires the ability to plan, undertake, and document experiments to verify and validate the device design in order to reliably and repeatedly produce a device, which meets the design input specification. Working closely with management and internal company engineers the electrical engineer will assure the long-term value and viability of products.

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

RESPONSIBILITIES

• Engineering design, analysis and verification for peripheral electrical subsystems including

  • Batteries and Charger

  • Console and User Interface

  • Power Supplies

• Create component specifications 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.

  • Develop 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 according to defined specifications.

  • Design test strategies, test procedures and test cases to verify the performance of components and systems

  • Create justifications for all test acceptance criteria.

  • Support the development of special tooling or fixturing to perform 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 which describe the testing procedures.

  • Application of interdisciplinary technical standards, principles, theories, concepts, and techniques.

• Conduct and report on experiments for verification and validation of 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 our client

  • 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 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

• Bachelor’s Degree in Electrical Engineering or equivalent.

• Experienced in design, prototyping, and testing of electronic circuits, components, and subsystems – min. 4 years.

• Practical implementation of electrical engineering principles for medical devices.

• Experience with digital and analog electronic device development.

• In-depth understanding of battery systems and performance and safety requirements for Li-Ion batteries

• Working knowledge of electromagnetic physics and analysis, EMC requirements, and test methods.

• Experienced with 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 electronic equipment such as spectrum analyzers, oscilloscopes and multi-meters.

• Experience working with vendors and contract manufacturers for PCB fabrication and assembly.