There are two jobs, one is available due to growth the other is a replacement.
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There are two jobs, one is available due to growth the other is a replacement. New client, same client as the Plant Manager position, I'm also working on. One is urgent to help support Assembly operations and the other for key medical customers 1. Electrical + mechanical assembly This is not just machining or general production. They want someone who has supported electronics, electromechanical assemblies, soldering, epoxy dispensing, tooling, fixtures, and manufacturing equipment. 2. Manufacturing process development They need someone who can write and maintain work instructions, process flows, procedures, validation documents, and engineering documentation. 3. NPI / transfer to production A big part of this job is taking products from design into production and making sure the process is scalable, repeatable, and documented. 4. APQP / PFMEA / Control Plans / MSA These are important keywords. The job specifically calls for APQP documentation including process flow diagrams, PFMEA, control plans, MSA studies, and process validation protocols. 5. Validation experience Ask about IQ/OQ/PQ, process qualifications, capability studies, and process control. That is a major clue this may be medical device or regulated manufacturing.
6. ISO 9001 / ISO 13485
ISO 13485 is medical-device quality. The job says medical-device manufacturing is preferred and specifically mentions ISO 9001 and ISO 13485 compliance. 7. Lean / Six Sigma / Kaizen / SPC / CAPA They want continuous improvement, root cause, failure investigations, corrective actions, and cost reduction—not just design engineering. Best keywords to search Use: "Manufacturing Engineer" AND (electromechanical OR electronics OR "electrical assembly") AND (soldering OR epoxy OR fixtures OR tooling) AND (PFMEA OR "control plan" OR APQP OR IQ OQ PQ) Also try: "Manufacturing Engineer" AND "ISO 13485" AND ("process validation" OR IQ OR OQ OR PQ) AND (assembly OR electromechanical) And: "Process Engineer" AND (soldering OR "epoxy dispensing" OR "electromechanical assembly") AND (CAPA OR PFMEA OR "control plans" OR SPC) Questions to ask candidates- What electromechanical or electronics assembly processes have you supported?”
- Have you worked with soldering, epoxy dispensing, potting, bonding, fixtures, tooling, or assembly workstations?”
- Have you led NPI transfer from design into production?”
- Have you created PFMEAs, control plans, process flows, work instructions, and validation protocols?”
- What IQ/OQ/PQ or process validation work have you done?”
- Have you worked under ISO 9001 or ISO 13485?”
- Tell me about a manufacturing problem you solved using root cause/CAPA.”
- What automation or equipment-integration projects have you supported?”
- What CAD tools have you used, especially SolidWorks?”
- Are you a U.S. person or protected individual for ITAR purposes?” The job requires ITAR eligibility.
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