Engineer

Overview

On Site
Full Time

Skills

Health Care
ISO 13485
Regulatory Affairs
Analytical Skill
Problem Solving
Conflict Resolution
GMP
Corrective And Preventive Action
Statistics
AutoCAD
SolidWorks
FMEA
Report Writing
Surveillance
Communication
Project Management
Microsoft Windows
Microsoft Excel
Microsoft PowerPoint
Web Browsers
Root Cause Analysis
Process Improvement
Collaboration
Manufacturing
Marketing
Documentation
Plant Lifecycle Management
Product Lifecycle Management
Windchill
Training

Job Details

Roles & Responsibilities:
  • 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.

Skills:
  • 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.