Process Engineer - Medical Devices
PROCESS ENGINEER (LANCASHIRE): LEADING BUSINESS IN THE MEDICAL DEVICE INDUSTRY. GREAT WORKING ENVIRONMENT AND ROLE, OPPORTUNITY NOT TO BE MISSED. COMPETITIVE SALARY DEPENDING ON EXPERIENCE PLUS COMPANY BENEFITS
Our client is a leader in the medical device industry. They are a prestige company offering a fantastic place to work and continued training and development. Due to the continued development and significant investment, we are looking for a Process Engineer as part of their technical team.
To establish and improve manufacturing methods and processes for a range of 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.
- Supports manufacturing by identifying opportunities and implementing improvements which improve quality, increase efficiencies and reduce waste.
- Develops work instructions, work flows, work stations and factory layouts.
- Utilises tools (including pFMEA) to achieve controlled process transfer from development to full scale production.
- Responsible for specification, procurement, installation management and commissioning of process and infrastructure equipment.
- Definition and documentation of production processes including the capturing of routings on the ERP system.
- 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.
Qualifications & Experience:
- A Bachelor of Science Degree and/or a minimum of five years of related professional experience
- Proven ability to manage and conduct internal and external audits is required, hence thorough understanding of the standards is required.
- Demonstrated knowledge and applied skills in quality-related methods and techniques are required including auditing principles and techniques, quality terminology, quality management principles and quality management tools.
- ISO or equivalent certification and/or training is highly preferred.
- Excellent written English-language skills are required appropriate to writing policies, standard operating procedures, work instructions, technical protocols and reports.
- Excellent verbal English-language communication skills are required appropriate to presenting technical issues and persuading colleagues and stakeholders regarding decisions, courses of action and their implications.
- Leadership, management and team working skills are required which facilitate building partnerships, both internally and externally, and leading teams through root cause analysis and problem solving.
- Clean room environment.
Is This You?
If the above describes you, then we want to speak to you. Send your CV to us and if you fit the bill then we will be in touch within 24 hours to discuss the role and our client in more detail.