Manufacturing Engineer

About the Role

We are seeking a hands-on Manufacturing Engineer to own the assembly, test, and continuous improvement of our ultrasound probe cell. In this on-site role, you will be the technical authority on the probe production floor, bridging R&D (mechanical, electrical, and software engineering) and factory operations.

You will define, document, and optimize processes for complex electromechanical medical devices across both sustaining production and new product introduction (NPI). If you are a strong root-cause problem solver who is comfortable with a soldering iron, an oscilloscope, and a technician's questions on the line, we want to hear from you.

Key Responsibilities

Process Engineering & Floor Support

• Probe Cell Ownership: Own probe assembly and test processes for both sustaining production and NPI builds.
• Assembly Line Engagement: Work directly alongside assembly technicians and operators to resolve daily technical issues, train on new processes, and streamline workflows.
• Process Optimization: Design, implement, and continuously improve assembly procedures, fixtures, tooling, test equipment, and cell layout to maximize yield, quality, and throughput.
• Special Builds: Build and rework engineering and test assemblies to support NPI, validation, and design engineering activities.

Troubleshooting & Failure Analysis

• Root Cause Analysis: Lead structured root cause investigations (e.g., 5 Whys, Fishbone, 8D, fault tree) on production failures and drive effective, verified corrective actions.
• Electrical Debug: Diagnose complex electromechanical failures at the component, sub-assembly, and system levels using schematics, multimeters, oscilloscopes, and other test equipment.
• Failure Analysis: Perform failure analysis on production rejects and customer returns, including teardown and cable dissection to isolate failure locations, in support of Service and Engineering.

Test & Production Systems

• Production Test: Support and troubleshoot production test systems, including acoustic output testing and reference data collection, in line with applicable standards.
• Production Software & Tools: Partner with software and electrical engineering to improve production software tools, test automation, and the transfer of new tools into production.
• Validation: Support equipment, process, and test method validation (IQ/OQ/PQ) and verification activities.

Continuous Improvement

• Data-Driven Focus: Analyze yield, defect, and NCR trend data to prioritize improvement efforts.
• Statistical Methods: Apply DOE and SPC to characterize, control, and improve processes.
• Cost & Capability: Identify, justify (ROI), and implement new fabrication or test methods and equipment that improve capability and reduce unit cost.

Documentation & Compliance

• Work Instructions: Author, edit, and maintain clear, visual Assembly Instructions (AIs), test and rework instructions, and Manufacturing Process Specifications (MPS) for mechanical housings, cabling, acoustic transducers, and PCB integration.
• DFM / DFT: Participate in NPI design reviews, advocating for Design for Manufacturability, Assembly, and Testability with design engineers and suppliers.
• Change Management: Prepare and manage Engineering Change Orders (ECOs), BOMs, and deviations in PLM to transfer designs and process changes into production.
• Quality & Regulatory: Maintain compliance with FDA QMSR (21 CFR Part 820), ISO 13485, and internal quality standards. Support NCRs and Corrective/Preventive Actions (CAPA).