Process Engineer
1 month ago
At WS Audiology, we're committed to delivering exceptional hearing solutions that transform lives. As a Process Engineer, you'll play a vital role in driving our business transformation by developing and enhancing processes that ensure compliance with ISO 13485 and FDA standards.
Key Responsibilities:
- Develop robust processes using Six Sigma methodologies to establish process control and ensure quality investigations.
- Characterize processes by identifying input variables and response variables, and establish FMEA, Control Plan, and Statistical Process Control.
- Ensure compliance with production and process control requirements, including PFMEA, EHS risk assessment, validation, and work instruction updates.
- Support investigation and failure analysis on ECM operations product and process-related quality issues.
- Maintain and update operation workflows, work instructions, and SMT component placement lists/drawings.
- Support alternate/source component qualification for engineering trials and implementation of strategic goals.
Requirements:
- Bachelor's degree in Mechanical, Mechatronics, Electrical, or Electronic Engineering.
- Minimum 3 years of relevant working experience in medical device/electronics/semiconductor manufacturing environments.
- Knowledge and experience in SMT/PCBA manufacturing processes.
- Experience in performing process characterization and/or process validation (IQ, OQ, PQ).
- Knowledge of Lean and/or Six Sigma methodologies, statistical software, and process simulation tools (e.g., MINITAB, JMP).
About Us:
WS Audiology is a leading provider of hearing solutions, driven by a passion to improve the quality of people's lives. We're committed to innovation, quality, and customer satisfaction.
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