|Date Posted||May 5, 2021|
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 external patient controller subsystem. With a superior technical ability, the electrical engineer (design verification) is required to develop system specifications, develop test methods and perform or supervise component, integration and system tests of the BiVACOR device. LOCATION: Cerritos, CA or Dallas/Ft Worth, TX
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.
- Specification of component and system test requirements for the external patient controller subsystem.
o Analyses product and software design input specifications in cooperation with team members from electrical, mechanical, and software engineering.
o 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.
o Design test strategies, test procedures and test cases to verify the performance of components and systems o Create justifications for all test acceptance criteria.
o Oversee development on special tooling or fixturing to perform testing.
o Define and justify test sample size(s), test conditions, and test apparatus.
o Establish traceability matrix from requirements through risk analysis to verification and validation tests.
o Review test protocols and reports from 3rd party testing.
o Oversee and manage 3rd party verification testing
o Create work instruction documentation which describe the testing procedures.
o Application of interdisciplinary technical standards, principles, theories, concepts, and techniques.
o 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.
o Plan, schedule, conduct and coordinate detailed phases of work relating to the validation and verification.
o Manage and ensure appropriate certifications for test equipment.
o Review manufacturing processes and manufacturing risk analysis and determine/justify which processes require process validation.
o Verify test coverage and consistency of devised testing procedures.
o Prepare and write formal test reports to be submitted to FDA and international regulatory agencies. o Technically supervise or liaise with/coordinate the work of technicians and external vendors.
- Feedback into the development, manufacturing, and support divisions of BiVACOR TAH
o Coordinate the development of specific test software required to verify design input requirements with the software development team.
o 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.
- Bachelor's Degree in Electrical Engineering or equivalent
Experienced in component, integration, and system tests - minimum 5 years
- Experience in the medical device development field is desired
- A strong understanding of medical device quality regulations, practices, and quality standards, such as IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11, ISO 13485, 14708-1, 14708-5, 14971 and FDA Quality System Regulations is required