JOB PROFILE: Production / ProcessEngineer (Medical Devices)

INCUMBENT’S NAME / New Position
JOB TITLE / Production / Process Engineer
BUSINESS UNIT / Production
LOCATION / Worthing
REPORTS TO / Operations Director
OBJECTIVES
PURPOSE OF JOB /
  • Part of a technical support team that provides engineering solutions for Product life cycle from New Product Introduction, Equipment and Process installation and validation through to Process Improvement and cost savings.
  • Use professional technical expertise to evaluate new and existing processes and configure manufacturing systems to reduce cost, improve sustainability and develop best practices within the existing manufacturing environment
  • Work across departments (including Operations, QA/Validation and R&D) to investigateand deliver the next generation of innovative and creative manufacturingsolutions to support new product development and business growth

KEY ACTIVITIES
RESPONSIBILITIES /
  • Maintain reliable and safe manufacturing systems
  • Utilise Root Cause Analysis methods to problem solve process issues and increase equipment reliability, process capability and product quality
  • Evaluate existing manufacturing processes by gathering observations from operators, liaising with equipment vendors, and applying knowledge of product design, fabrication, assembly, tooling, and materials
  • Use this evaluation to implement projects designed to improve production rates, efficiencies, yields, costs and product quality
  • Where necessary, organise and perform process validation to appropriate regulatory standards for the Medical Device Industry
  • Work closely with R&D and QA/Validation departments to support the development, validation and transfer of new products into manufacturing, as well as developing the next generation of processing equipment using innovative technologies
  • Ensure maintainance ofregulatory compliance at all times
  • Maintain a high standard of professional and technical knowledge by attending educational training/workshops; reviewing professional publications; establishing networks; participating in professional societies

KEY PERFORMANCE INDICATORS / Based on annual performance objectives
KEY RELATIONSHIPS / Internal:
  • All production employees
  • Materials Manager
  • Production Planner
  • R&D
  • QARA
  • Validation
  • Purchasing
  • IT
/ External:
  • Suppliers

CANDIDATE PROFILE:

QUALIFICATIONS/TRAINING / Preferable:
  • Educated to Degree level in engineering, biological sciences, physical sciences or a related field.
  • Lean Six Sigma qualified

EXPERIENCE
(e.g. health care industry, multinational company, what level/types of roles, etc) / Essential:
  • Solid experience as a manufacturing/process engineer
  • Practical working knowledge ofNew Product Introduction / Lean manufacturing and / or process automation
  • Involvement with Process Validation
Preferable:
  • Working in healthcare/medical devices industry
  • Working in GMP environment
  • A working awareness of medical device regulations and the medical device directive (ISO13485, FDA QSR 21, CFR 820 etc.)
Involvement with Process Validation
  • Using 3D CAD software

COMPETENCIES
(knowledge, skills and attributes – including language requirements, ability to travel, etc) /
  • Excellent problem solving skills
  • Confident communicator
  • Adept at building strong working relationships with employees of all levels
  • Strong planning and organising skills
  • Good time management
  • Analytical approach
  • Creative thinker
  • Strong attention to detail
  • Passionate about continuous improvement, includingLean/Six Sigma methodologies

This job description is a guide only and will be periodically reviewed due to the evolving nature of our business. You will be required to take on other tasks and responsibilities from time to time depending on business need for this role.

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