The Test Engineer shall participate in product deployment, sustaining and development activities. This position will apply self-directed and diversified knowledge of engineering principles and practices for performing automated test system development and maintenance for manufacturing.
Responsible for test systems to support production testing of implantable pulse generators as well as external support devices such as chargers, remotes, etc.
Development activities include definition of verification and validation test plans, design and execution of test protocols and preparing reports.
Perform IQ/OQ/PQ of test systems.
Yield analysis and trending for improving quality and reducing the cost of products.
Determine and pursue a course of action necessary to obtain desired results.
Proactively identify areas of developmental risk and communicate to management accordingly.
Assemble the different manufacturing test systems in the Nevro lab and make them ready for installation at the various production sites. Run ad hoc testing on these test systems and report any issues in a timely manner to help improve the systems and make them ready for installation at the various production sites.
Document new or modified test fixtures or other equipment (developed at Nevro or purchased from vendors) in the Nevro document control system to formalize their use in the manufacturing test systems.
Help with coordinating and performing the repair/replacement/calibration of test fixtures at the various manufacturing sites.
Ability to read technical drawings, schematics, and BOMs.
Work in accordance with quality system procedures and actively enforce its objectives.
Develop software in a regulated environment in accordance with internal operating procedures and external standards and regulations is desirable. Conduct cross-functional reviews of the software development at appropriate times in the development cycle.
Maintain engineering lab test equipment and be the point person in coordinating lab activities with the R&D group.
Other duties as assigned
Responsibilities
Bachelor’s Degree in Engineering (Electrical Engineering, Computer Science, or Biomedical). A graduate degree is a plus
A minimum of 5 years experience in a regulated industry. Prior medical device experience is preferred.
Qualifications
A minimum of 5 years experience in automated test system deployment, sustaining, and development, preferably using National Instruments LabVIEW and Test Stand is desired
Good analytical and problem-solving skills
Prior experience working with contract manufacturers
Experience in implantable medical device development is a plus.
Functional familiarity with the FDA Submission process, ISO Requirements, and QSR requirements is a plus.
Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.
