Job ID: JOB_ID_2629
Role and Responsibilities
The Manufacturing Test Engineer will be a pivotal member of the engineering team in Skaneateles, NY, focusing on the development and deployment of Automated Test Equipment (ATE) for medical device production. This role requires a sophisticated blend of hardware engineering and software development skills. The engineer will be responsible for the entire lifecycle of test systems, starting from the initial requirement gathering phase where they collaborate with R&D product engineers to define what needs to be tested and how. Following this, the engineer will design the ATE architecture, selecting appropriate hardware components such as National Instruments PXI chassis, data acquisition modules, and various benchtop instruments like oscilloscopes and digital multimeters. On the software side, the engineer will utilize LabVIEW and TestStand to create automated test sequences that are both efficient and reliable. The use of C# and the .NET framework will be necessary for developing custom user interfaces and integrating the test systems with enterprise databases. A significant portion of the role involves the fabrication of the test fixtures themselves, requiring hands-on skills in electronics and mechanical assembly. Once the systems are built, the engineer will lead the validation process, ensuring that the equipment meets all regulatory requirements, including those set by the FDA for medical device manufacturing. This includes performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The engineer will also be responsible for troubleshooting any issues that arise during the deployment phase and providing ongoing support to the manufacturing team to ensure minimal downtime. Continuous improvement initiatives, such as optimizing test times and increasing test coverage, will be a regular part of the job. The engineer must maintain meticulous documentation, including design specifications, wiring diagrams, and software version control using tools like Azure DevOps. This position offers a 12-month contract with the potential for extension, providing a stable yet challenging environment for an experienced engineer to apply their skills in a meaningful way.
Technical Environment and Standards
Working in the medical device industry requires a high level of precision and adherence to quality standards such as ISO 13485. The Manufacturing Test Engineer must be familiar with these standards and how they apply to test equipment. The technical environment is characterized by a mix of legacy systems and cutting-edge technology. Proficiency in communication protocols like UART, GPIB, and Ethernet/TCP is essential for interfacing with various sub-assemblies. The engineer will also work with PLCs to control automated assembly lines and integrate them with the test stations. Knowledge of SQL is required for logging test data and generating reports that are used for quality assurance and process improvement. The ideal candidate will have a strong background in object-oriented design and be able to write clean, maintainable code. This role is onsite in Skaneateles, NY, a region known for its beautiful landscapes and its concentration of medical technology companies. The engineer will benefit from working in a collaborative environment where innovation is encouraged and where their contributions directly impact the safety and efficacy of medical products used worldwide. Furthermore, the role involves working with R&D product engineers to define requirements and with manufacturing to determine manufacturing needs. The engineer will work with manufacturing during deployment and production to assess equipment robustness and implement changes for continuous improvement. They will develop requirements, create design documentation, and perform code reviews, unit tests, software, and system validation. The candidate should have experience using instrumentation like oscilloscopes, DMMs, power supplies and signal generators, and experience with communications busses like UART / Serial, GPIB, USB and Ethernet / TCP. Strong Object-Oriented development and design knowledge and experience are required.
Special Requirements
Onsite in Skaneateles NY. 12+ Months Contract. Medical Device industry focus.
Compensation & Location
Salary: $110,000 – $150,000 per year (Estimated)
Location: Skaneateles, NY
Recruiter / Company – Contact Information
Recruiter / Employer: DMS Visions Inc
Email: raveena@dmsvisions.com
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