JobsUSAEngineer
Company : Katalyst HealthCares & Life Sciences
Location : Los Angeles, CA, 90079
Posted Date : 15 September 2025
Job Details
- 4-6 years Minimum bachelor's or master's degree in a health-care related field
- Strong knowledge of GMP (Good Manufacturing Practices) and ISO 13485 standards, along with regulatory affairs.
- Strong creative, analytical, and problem-solving skills.
- Proficient in interpreting data and compiling detailed reports.
- Expertise in Design Quality, Good Manufacturing Practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, and Manufacturing Processes.
- Expertise in statistical analysis and root cause analysis.
- Strong CAD skills (preferred: AutoCAD and SolidWorks).
- Experience in fixture design, FMEA creation, and report writing.
- Knowledge of Post Market Surveillance (PMS) and PLM tools (Windchill).
- bility to observe, understand, and optimize manufacturing processes.
- Excellent interpersonal, communication, organizational, and project management skills.
- Proficiency in Windows-based software (Word, Excel, PowerPoint, email, and web browsers).
- bility to work efficiently, meet deadlines, and communicate project status effectively.
- Investigate field return products and perform root cause analysis.
- Optimize manufacturing processes and work with stakeholders to reduce scrap.
- Identify and implement process improvement opportunities.
- Support design enhancement initiatives.
- Collaborate with cross-functional teams (engineering, manufacturing, marketing, and suppliers).
- Create Engineering Change Orders (ECOs) to update documentation in the PLM system (Windchill).
- dhere to company policies, procedures, and training requirements.
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