Essential Functions:- Responsible for full lifecycle of the custom electro-mechanical test systems to support production testing of Nevro products. This includes developing the test requirements, design/development, and verification and validation activities (V&V, IQ/OQ/PQ).
- Perform and recommend test coverage analysis/strategy (DFT) on new designs from PCBA testing to Final Product Acceptance Testing.
- Perform regression testing on modified electro-mechanical test systems.
- Assist in circuit/ electrical troubleshooting of production test failures, perform root cause analysis, implement corrective actions, and drive efforts improve first pass yield at suppliers and manufacturing sites.
- Conduct ad hoc testing on test systems and report any issues in a timely manner to help improve the electro-mechanical test systems.
- Apply self-directed and diversified knowledge of engineering principles and practices for performing automated electro-mechanical test system development and maintenance for manufacturing. Determines and pursues courses of action necessary to obtain desired results. Proactively identifies areas of developmental risk and communicates these to management accordingly.
- Ability to travel up to 10% - domestical and international visit to suppliers or manufacturing sites
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications- B.S. in electrical/ electronics engineering, computer science, electro-mechanical/ mechatronics engineering or equivalent experience.
- A minimum of 5 years' experience in automated electro-mechanical test system deployment, sustaining and development, preferably using National Instruments LabVIEW and TestStand is desired
- Experience in medical devices or other regulated industries (e.g., aerospace, automotive) is preferred
- Recent hands-on development experience with PXI test equipment using NI LabView, TestStand is a plus
- Development experience using Microsoft .NET C# is a plus
- Experience with writing SQL queries and generating database reports is a plus
- Strong troubleshooting skills; Proficiency in Electronic hardware, including data acquisition, oscilloscope, etc. Understanding of technical drawings, electrical schematics, and BOMs is a plus.
- Understanding of good software development and testing practices
- Ability to manage multiple priorities, and drive projects to completion in a cross-functional environment.
- Ability to work independently and as part of a team, with flexibility to adapt to changing requirements.
- Experience in the verification and validation of software and software systems in compliance with FDA regulations, in medical devices or healthcare, is preferred.
- Ensure compliance of the organization's management systems to guarantee effectiveness and adherence to established policies, standards, and regulatory requirements.
Physical Demands:The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
