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).

Qualifications

Qualifications & Skill Requirements

Education & Experience (one of the following)

• Bachelor's degree in Mechanical, Electrical, Manufacturing, or Biomedical Engineering (or a related discipline) plus 3+ years of manufacturing, test, or process engineering experience; or
• 5+ years of hands-on manufacturing, test, or process engineering experience in a high-reliability hardware environment.

Required Skills

• Root Cause Analysis: Demonstrated track record of solving complex production problems with structured RCA methods and verifying the fix.
• Electrical Debug & Soldering: Strong hands-on electrical troubleshooting skills, including reading schematics and using a multimeter and oscilloscope; proficient in fine-pitch soldering and rework of PCBAs, wire harnesses, and cables.
• Electromechanical Fundamentals: Working knowledge of electrical systems (PCBAs, harnesses, sensors, power distribution) and mechanical assemblies (precision tolerances, enclosure fit, structural hardware).
• Lean & Quality Tools: Experience applying Lean Manufacturing (5S, Kaizen, Value Stream Mapping, Kanban), pFMEA, DOE, and SPC.
• Data Analysis: Advanced Excel skills and comfort with statistical software for analyzing yield and defect data.
• Regulated Environment: Experience in an ISO 13485 / FDA-regulated medical device environment is highly preferred; experience with other regulated or high-reliability electromechanical products will be considered.

Preferred Skills (a Plus)

• Python Scripting: Ability to write or modify Python scripts for test automation, data collection, or analysis.
• Linux / Ubuntu: Familiarity with Ubuntu or other Linux environments, including the command line, as used on production test stations.
• 3D CAD: Proficiency in SolidWorks, Creo, or similar for designing fixtures and jigs and creating visual assembly illustrations.
• Ultrasound Knowledge: Experience with transducer/probe assembly, acoustic shielding, coaxial cabling, high-frequency signal integrity, or acoustic output testing.
• Mobile Platforms: Familiarity with Android or iOS devices and applications used in production or test.
• PLM Systems: Experience managing change orders and BOMs in a Product Lifecycle Management system.
• Certifications: IPC J-STD-001 or IPC-A-610 certification.

Soft Skills & Working Style

• Excellent written and verbal communication, with a proven ability to write crisp, unambiguous visual work instructions.
• High emotional intelligence and the interpersonal skills to build trust with assembly technicians, quality engineers, and R&D designers.
• Ability to prioritize and manage multiple assignments while maintaining a high level of quality.