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Electromechanical Systems Testing Specialist
2 months ago
Company Background
RefleXion Medical is at the forefront of transforming radiopharmaceuticals from mere diagnostic tools into active guides for external beam radiotherapy, utilizing insights from tumor biology. Our SCINTIX therapy, recognized as an FDA Breakthrough Device for lung tumors, aims to eliminate traditional barriers to effective radiotherapy for metastatic conditions. This FDA-cleared technology automates the targeting and management of motion in FDG-guided treatments for lung and bone tumors, whether they originate from primary sites or are metastatic in nature. Through strategic partnerships with leading radiopharmaceutical firms, we are co-developing and co-marketing disease-specific radiotracers aimed at treating advanced-stage cancers.
Role Summary
The Electromechanical Systems Testing Specialist will be responsible for conducting the final evaluation of a sophisticated electromechanical radiation therapy device as part of standard manufacturing procedures. This position necessitates close collaboration with System Test Engineers and the application of established processes to diagnose and rectify assembly issues. The role demands versatility and familiarity with various technical domains, including delicate electrical connections, substantial mechanical assembly, precise alignments, and the execution of software scripts. The Specialist will carry out system-level testing and may receive training for additional manufacturing responsibilities across various areas of the production floor, such as electrostatic discharge (ESD), sub-assembly, gantry, and system testing.
Key Responsibilities
- Program, configure, troubleshoot, and assess various subsystems as part of comprehensive final evaluations of the RefleXion systems.
- Collaborate with engineering teams to implement assembly and testing processes while providing constructive feedback for design and procedural enhancements.
- Conduct Factory Acceptance Testing for complete systems in preparation for customer delivery.
- Identify and troubleshoot failures, coordinating Non-Conformance Reports (NCRs) and reworks as necessary.
- Work alongside System Test Engineering to resolve arising issues and assist in creating the required documentation for resolution.
- Integrate system-level components, including gantry, power distribution units, uninterruptible power supplies, control racks, treatment couches, and associated electronics and cabling.
- Adhere to scheduled timelines and provide daily progress updates.
- Compile production records to ensure compliance and accuracy.
- Maintain testing vaults and tools in the testing areas.
- Assist in aligning, fitting, or assembling components using hand or power tools, fixtures, and other assembly aids as necessary.
- Verify the accuracy of components and maintain traceability for jobs.
- Ensure precise component traceability and associated build documentation.
- Perform necessary repairs and upgrades to systems as required.
- Support investigations to address quality concerns such as Non-Conformance Material Reports (NCMRs), complaints, and Corrective and Preventive Actions (CAPAs).
- Comply with all quality, safety, and housekeeping protocols.
- Undertake additional duties as assigned.
Work Environment
This position requires the successful candidate to work onsite at RefleXion Medical.
Qualifications
- High school diploma or GED with a minimum of 8 years of professional experience as a test technician, or an Associate's degree in computer science or a related technical field with 4 years of experience, or a Bachelor's degree (BS/BA).
- Proficient understanding of Lean Manufacturing principles, including 5S, waste reduction, one-piece workflow, and quality integration.
- Experience in large system programming, adjustment, calibration, and testing is essential.
- Possess the necessary demeanor to thrive in a fast-paced manufacturing environment while maintaining a focus on safety and quality.
- Ability to perform system-level testing with meticulous attention to detail and product quality.
- Capability to routinely lift heavy objects up to 50 pounds, as some sub-assemblies require movement during assembly or testing.
- Ability to read and interpret electronic circuit and mechanical schematics, along with detailed process instructions.
- Prior manufacturing experience in a highly regulated industry (e.g., medical devices, aerospace, semiconductor, government) is preferred.
- Proficient with basic hand tools and inspection equipment.
- A strong team player with effective communication skills.
Preferred Qualifications
- Experience in medical device manufacturing is advantageous.
- Scientific or engineering education and/or experience is a plus.
- Strong attention to detail in documentation and traceability is highly valued.
Benefits of Joining Our Team
- Opportunity to collaborate with a passionate and driven team in a dynamic pre-IPO startup environment.
- Flexible work arrangements and schedules available for many roles.
- Competitive compensation packages, including pre-IPO stock options.
- Comprehensive medical, dental, and vision insurance options.
- Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care Flexible Spending Account (DCFSA).
- Pre-tax commuter benefits.
- Employee Assistance Program (EAP).
- 401(k) retirement plan.
- Generous paid time off and holiday schedule.
- Employer-paid life insurance and short- and long-term disability coverage.
- Exclusive discounts and deals through the RefleXion Benefit Hub.
- Weekly catered lunches and well-stocked kitchens with healthy food options.
- Engaging employee events, workshops, and opportunities for professional development.
- On-site electric car charging stations.
Commitment to Diversity
RefleXion Medical is an equal opportunity employer. All employment decisions will be based on merit, competence, performance, and business needs, without discrimination based on race, color, religion, marital status, age, national origin, ancestry, disability, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected by law.