Electrical Engineer - BiVACOR

Electrical Engineer (Design Verification)

The Electrical Engineer (design verification) will be an integral member of the BiVACOR engineering team, responsible for verification and validation of all aspects of the BiVACOR implantable artificial heart, with a focus on the peripheral electronic components and assemblies. With a superior technical ability, the electrical engineer (design verification) is required to develop system specifications, develop test methods, perform, or supervise component, integration and system tests of the BiVACOR device, and interface with external suppliers to ensure peripheral system components meet system and product requirements. The Electrical Engineer (design verification) is the responsible point of contact for external suppliers in the development of peripheral subsystems such as batteries, AC Adapters, or tablet computers and will manage the required safety certifications for all peripheral electronic assemblies including the system safety certification to IEC 60601-1 and applicable collateral standards.

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 (design verification) will assure the long-term value and viability of products

.For the location in Huntington Beach (CA), BiVACOR is looking for motivated and flexible team members with superior communication and organizational skills, 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

• Devise the strategy for safety and essential performance certification of the electronic subassemblies and peripheral components of the BiVACOR TAH System
• Develop and maintain safety and functional performance requirements for newly introduced electronic subassemblies and peripheral components.
• Specify insulation strategies, means of protection, and develop test requirements for system certification to IEC 60601-1 and applicable collateral standards.
• Define input requirements and required external certifications for subsystems and components such as batteries, AC Adapters, or peripheral components connected to the BiVACOR System.
• Liase with external test houses to define test sequences, define and provide references to internal documentation, and manage certification activities to the relevant safety, electromagnetic compatibility, and risk management requirements.

• 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 subsystems.
• Create justifications for all test acceptance criteria.
• Oversee development on special tooling or fixturing to perform testing.
• Define and justify test sample size(s), test conditions, and test apparatus.
• Establish traceability matrix from requirements through risk analysis to verification and validation tests.
• Review test protocols and reports from 3rd party testing.
• Oversee and manage 3rd party verification and certification testing.
• Create work instruction documentation which describe the testing procedures.
• Application of interdisciplinary technical standards, principles, theories, concepts, and techniques.
• Identification, design, installation and validation of test fixtures and measurement equipment.

• Conduct and report on experiments for verification and validation of the product input specifications.
• Plan, schedule, conduct and coordinate detailed phases of work relating to the validation and verification.
• Manage and ensure appropriate certifications for test equipment.
• Verify test coverage and consistency of devised testing procedures.
• Prepare and write formal test reports to be submitted to FDA and international regulatory agencies.
• Technically supervise or liaise with/coordinate the work of technicians and external vendors.

• Feedback into the development, manufacturing, and support divisions of BiVACOR TAH
• Coordinate the development of specific test software required to verify design input requirements with the software development team.
• Participate in failure and risk analysis / corrective action activities in order to determine and direct design modifications and support regulatory submissions of specifications, test plans, and reports.

REQUIREMENTS

• Bachelor’s Degree in Electrical Engineering or equivalent (essential).
• Minimum of 3 years of experience in the development of component, integration, and system test requirements and procedures, preferably in the class II/III medical device industry (essential)
• A strong understanding of medical device quality regulations, practices, and quality standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 62133-2, ISO 13485, ISO 14708-1, ISO 14708-5, ISO 14971 and applicable regulations is required (essential)
• Working knowledge of electromagnetic physics and analysis, EMC requirements and test methods (essential).
• Detailed understanding of battery systems, including an understanding of different chemistries and associated performance characteristics, requirements, and safety mechanisms (desirable).
• Experience in the specification of design output documentation and liaison with external suppliers and contract manufacturers (desirable).

BiVACOR offers a competitive compensation package to include 401k with above-average employer contributions, generous amount of time off, a choice of rich healthcare plans and an array of other benefits

About the Company

BiVACOR is a clinical-stage medical device company pioneering the development of a long-term therapy for patients with biventricular heart failure. Under the expert direction of its founder and TAH inventor, Daniel Timms, PhD, and the guidance of two luminaries in cardiovascular surgery, William E. Cohn, MD, and O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an FDA-approved first-in-human Early Feasibility Study (EFS). Headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia, BiVACOR is committed to addressing the global unmet need of patients with end-stage heart failure awaiting transplant by providing the next generation of life-extending solutions. 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. To learn more about us go to www.bivacor.com.

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 hr@bivacor.com.

BiVACOR does not accept profiles or resumes from recruiting firms without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by BiVACOR, implied or otherwise.