KH
Sr. Manufacturing Engineer
Katalyst Healthcares & Life Sciences
🇵🇱 Poland | 🇺🇸 United States
On-site
Senior
1 month ago
- GMP
- Risk Management
- FMEA
- CAPA
- calibration
- CNC
- Minitab
- JMP
1 month ago
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
Sr. Manufacturing Engineer · Katalyst Healthcares & Life Sciences