Immediate Support needed on priority with medical domain experience must.(Sr. Manufacturing engineer KTEK RESOURCING
IN4 days ago
- Contractor
Highlights
Requirements: Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or a related field. Strong knowledge of ISO 13485, GMP, 21 CFR Part 820, and ISO 14971 risk management principles.
Numbers & Facts
| Location | Warsaw, IN |
Description
Summary:
We are looking for an experienced Sr. Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated environment.
Requirements:
We are looking for an experienced Sr. Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated environment.
Requirements:
- Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or a related field
- 5+ years of experience in manufacturing and equipment validation (MedTech, Pharma, or Healthcare Devices)
- Strong knowledge of ISO 13485, GMP, 21 CFR Part 820, and ISO 14971 risk management principles
- Hands-on experience developing and executing IQ/OQ/PQ validation protocols
- Expertise in Master Validation Plans, FMEA, CAPA, and validation documentation
- Experience with metrology, calibration, Gauge R&R, and Measurement System Analysis (MSA)
- Knowledge of CNC machines, CAM software, and basic CNC programming concepts
- Experience with statistical analysis tools such as Minitab or JMP for process capability studies
- Familiarity with Document Control and eQMS platforms such as Master Control or ETQ
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