Process Engineer II
ACE Partners, Austin, TX, United States
We are looking for a Process Engineer II to provide dedicated engineering support to our machine shop operations.
This is a hands-on, floor-facing role. You will work directly with our machining team to troubleshoot equipment issues, drive process improvements, support new equipment installations, and maintain the engineering rigour our regulated environment demands. You will collaborate closely with a senior engineer already embedded in the area.
What you will be doing:
Troubleshooting CNC equipment failures and leading root cause investigations on the floor
Supporting process improvement initiatives within the machine shop
Executing and documenting IQ/OQ/PQ for new equipment installations and process changes
Managing engineering change notices and change management processes
Conducting nonconformance investigations and developing disposition plans
Providing technical support to suppliers of key machining components and equipment
Creating and improving SOPs, part specifications, and process documentation
Supporting audits and CAPA deliverables as assigned
Looking for:
Experience in a medical device or similarly regulated environment with genuine QMS discipline — change management, validation protocols, and quality system adherence
Advanced CNC machining experience - specifically 5-axis milling and/or advanced grinding processes. You should have physically run these machines and be comfortable troubleshooting them to root cause
Experience drafting and executing IQ/OQ/PQ (installation, operation, and performance qualifications)
Experience conducting nonconformance investigations and writing disposition plans
Familiarity with CAD software and PLC-controlled processes
Green Belt / Lean / 5S knowledge (preferred, not required)
Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field)
2–5 years of relevant engineering experience (1–3 years with a Master's in Engineering)
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This is a hands-on, floor-facing role. You will work directly with our machining team to troubleshoot equipment issues, drive process improvements, support new equipment installations, and maintain the engineering rigour our regulated environment demands. You will collaborate closely with a senior engineer already embedded in the area.
What you will be doing:
Troubleshooting CNC equipment failures and leading root cause investigations on the floor
Supporting process improvement initiatives within the machine shop
Executing and documenting IQ/OQ/PQ for new equipment installations and process changes
Managing engineering change notices and change management processes
Conducting nonconformance investigations and developing disposition plans
Providing technical support to suppliers of key machining components and equipment
Creating and improving SOPs, part specifications, and process documentation
Supporting audits and CAPA deliverables as assigned
Looking for:
Experience in a medical device or similarly regulated environment with genuine QMS discipline — change management, validation protocols, and quality system adherence
Advanced CNC machining experience - specifically 5-axis milling and/or advanced grinding processes. You should have physically run these machines and be comfortable troubleshooting them to root cause
Experience drafting and executing IQ/OQ/PQ (installation, operation, and performance qualifications)
Experience conducting nonconformance investigations and writing disposition plans
Familiarity with CAD software and PLC-controlled processes
Green Belt / Lean / 5S knowledge (preferred, not required)
Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field)
2–5 years of relevant engineering experience (1–3 years with a Master's in Engineering)
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