Manufacturing Engineer - Level II
On-siteAustin, Texas, United States
Austin, Texas, United StatesOn-siteFull TimeSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Design, develop, and implement automated control systems, PLCs, and HMIs to enhance manufacturing efficiency and reliability for medical devices. Program logic controllers, troubleshoot system issues, and lead engineering change control while ensuring full compliance with FDA, ISO 13485, and safety standards. Collaborate with R&D and Quality teams to define automation needs, conduct risk assessments, and execute process validations. Assume ownership of new production equipment selection, scale-up of existing processes, and development of new manufacturing aids. Maintain detailed documentation, including schematics and code, and lead training for Manufacturing and Quality personnel on new technologies and safety protocols.
Required Qualifications
- Bachelor's degree in relevant engineering discipline
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, Automation Engineering, or a related field
- 2+ years of experience in control/automation engineering
- Experience in the medical device or a similar regulated industry
- Proficiency in programming and configuring HMI systems
- Data analytics experience (SQL, Tableau, Power BI)
- Experience programming in Python (Scripting and Automation)
- Advanced user of SolidWorks
- Excellent problem-solving skills and attention to detail
- Strong communication and teamwork skills
- Experience with SCADA systems and industrial networks
- Equipment integration experience using IIoT, OPC and/or PTC Kepware
- Ability to debug electrical, mechanical & micro fluidics components
- Expertise in developing requirement for sensors and actuators
- Thorough knowledge of ISO 13485 and FDA Quality System requirements
- Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
- Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
- Proven results through application of Six Sigma and Lean Manufacturing principles
- Mathematics and statistics aptitude
- Data analysis and technical writing aptitude
- Excellent oral and written communication skills
- Geometric Dimensioning & Tolerancing
- CAD/design/engineering exposure
- PLC programming
- Proficient in Microsoft Word, Excel, and PowerPoint programs
- Highly organized with proven time management and prioritization skills
- Ability to work independently and with minimal supervision
- Ability to handle the pressure of meeting tight deadlines
- Familiarity with LabVIEW, MATLAB, or other automation software
- Experience with robotics and motion control systems
- Certification in Quality Assurance or related fields (e.g., ASQ, Six Sigma)
- 10% Travel may be required up to 10% of the time
Desired Qualifications
- Bachelor's degree in relevant engineering discipline; electrical, automation, or process control preferred
- Experience in the medical device or a similar regulated industry
- Data analytics experience (SQL, Tableau, Power BI)
- Experience programming in Python (Scripting and Automation)
- Advanced user of SolidWorks
- Excellent problem-solving skills and attention to detail
- Strong communication and teamwork skills
- Experience with SCADA systems and industrial networks
- Equipment integration experience using IIoT, OPC and/or PTC Kepware
- Ability to debug electrical, mechanical & micro fluidics components
- Expertise in developing requirement for sensors and actuators
- Thorough knowledge of ISO 13485 and FDA Quality System requirements
- Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
- Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
- Proven results through application of Six Sigma and Lean Manufacturing principles
- Mathematics and statistics aptitude
- Data analysis and technical writing aptitude
- Excellent oral and written communication skills
- Geometric Dimensioning & Tolerancing
- CAD/design/engineering exposure
- PLC programming
- Proficient in Microsoft Word, Excel, and PowerPoint programs
- Highly organized with proven time management and prioritization skills
- Ability to work independently and with minimal supervision
- Ability to handle the pressure of meeting tight deadlines
- Familiarity with LabVIEW, MATLAB, or other automation software
- Experience with robotics and motion control systems
- Certification in Quality Assurance or related fields (e.g., ASQ, Six Sigma)
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