Process Engineer: Plastic Medical Devices
- Recruiter
- BCT Resourcing
- Location
- Blackburn, Lancashire
- Salary
- 0
- Posted
- 20 Apr 2017
- Closes
- 18 May 2017
- Ref
- 1406262
- Sectors
- Engineering, Chemical, Design
- Contract Type
- Permanent
- Hours
- Full Time
Position: Process Engineer: Plastic Medical Devices
Location: Blackburn BB1
Job type: Permanent
PURPOSE OF JOB:
To establish and improve plastics conversion processes (injection moulding and extrusion) for a range of disposable medical devices. Responsible for the design and execution of validations to support the smooth transition of products and processes from development to full scale production.
KEY RESPONSIBILITIES:
Responsible for specification, procurement, installation management and commissioning of process and infrastructure equipment.
Initial training of trainers and operators in the operation, setting and basic trouble shooting of plastic moulding and extrusion equipment.
Definition and documentation of production processes including the capturing of routings on the ERP system.
Utilise tools (including pFMEA) to achieve controlled process transfer from development to full scale production.
Design of Validation Master Plans (VMP), Validation protocols, execution of Validations and the generation of Validation reports (for both internal and external processes).
Collate and analyse data and generate technical reports.
Management of equipment calibrations and management of calibration registers.
Management of asset registers.
Definition of critical spares lists for production and infrastructure equipment.
Conducts deviation investigations and troubleshoots and resolves issues as needed.
Support of change control process related to BOM's, Work Instructions, Drawings, Specifications and Travellers.
Supports manufacturing by identifying opportunities and implementing improvements which improve quality, increase efficiencies and reduce waste.
ADDITIONAL RESPONSIBILITIES:
Provide project support to the Engineering/Development teams.
Provide specialist project support to Operations (where required) on site expansion, significant changes to processes or business structure.
Second line support to production on process support and improvement.
QUALIFICATIONS AND EXPERIENCE:
Essential:
Bachelor's degree or equivalent in a relevant technical discipline.
Experienced in the practical application of engineering principles.
Thorough understanding of the principles and practice of plastic moulding plus a basic understanding of plastic extrusion.
Knowledge of Design Control Systems and ability to apply project management techniques.
Experience of Product transition from development to full scale production.
Demonstrated knowledge of Good Manufacturing Practice (GMP).
Effective oral and written communication.
Preferred:
2+ years’ experience within the medical or pharmaceutical manufacturing sectors.
Knowledge of Standards Applicable to Medical Device Safety Risk Management (ISO 13485, ISO 14971 and related standards)
Certified practitioner in Six Sigma (DFSS or DMAIC) or Kaizen techniques.
Use of statistical packages for analysis (e.g. MINITAB or similar).
Experience managing a risk management process for medical devices (pFMEA/dFMEA) or similar.
Knowledge of validation and the use of Design of experiment
Experience with supplier management and component qualification practices
________________________________________
Benefits:
Growing business, pension, commission/bonus, attractive hours.
Additional Information
Benefits
Pension, Commission/Bonus
Key skills
Theoretical & practical expertise in plastic processing (injection moulding & extrusion). Good understanding of GMP. Experience of validation processes.
Location: Blackburn BB1
Job type: Permanent
PURPOSE OF JOB:
To establish and improve plastics conversion processes (injection moulding and extrusion) for a range of disposable medical devices. Responsible for the design and execution of validations to support the smooth transition of products and processes from development to full scale production.
KEY RESPONSIBILITIES:
Responsible for specification, procurement, installation management and commissioning of process and infrastructure equipment.
Initial training of trainers and operators in the operation, setting and basic trouble shooting of plastic moulding and extrusion equipment.
Definition and documentation of production processes including the capturing of routings on the ERP system.
Utilise tools (including pFMEA) to achieve controlled process transfer from development to full scale production.
Design of Validation Master Plans (VMP), Validation protocols, execution of Validations and the generation of Validation reports (for both internal and external processes).
Collate and analyse data and generate technical reports.
Management of equipment calibrations and management of calibration registers.
Management of asset registers.
Definition of critical spares lists for production and infrastructure equipment.
Conducts deviation investigations and troubleshoots and resolves issues as needed.
Support of change control process related to BOM's, Work Instructions, Drawings, Specifications and Travellers.
Supports manufacturing by identifying opportunities and implementing improvements which improve quality, increase efficiencies and reduce waste.
ADDITIONAL RESPONSIBILITIES:
Provide project support to the Engineering/Development teams.
Provide specialist project support to Operations (where required) on site expansion, significant changes to processes or business structure.
Second line support to production on process support and improvement.
QUALIFICATIONS AND EXPERIENCE:
Essential:
Bachelor's degree or equivalent in a relevant technical discipline.
Experienced in the practical application of engineering principles.
Thorough understanding of the principles and practice of plastic moulding plus a basic understanding of plastic extrusion.
Knowledge of Design Control Systems and ability to apply project management techniques.
Experience of Product transition from development to full scale production.
Demonstrated knowledge of Good Manufacturing Practice (GMP).
Effective oral and written communication.
Preferred:
2+ years’ experience within the medical or pharmaceutical manufacturing sectors.
Knowledge of Standards Applicable to Medical Device Safety Risk Management (ISO 13485, ISO 14971 and related standards)
Certified practitioner in Six Sigma (DFSS or DMAIC) or Kaizen techniques.
Use of statistical packages for analysis (e.g. MINITAB or similar).
Experience managing a risk management process for medical devices (pFMEA/dFMEA) or similar.
Knowledge of validation and the use of Design of experiment
Experience with supplier management and component qualification practices
________________________________________
Benefits:
Growing business, pension, commission/bonus, attractive hours.
Additional Information
Benefits
Pension, Commission/Bonus
Key skills
Theoretical & practical expertise in plastic processing (injection moulding & extrusion). Good understanding of GMP. Experience of validation processes.