Process Engineer
other jobs Lynx Recruitment Ltd
Added before 2 Days
- England,London,City of London
- Full Time, Permanent
- £40,000 - £50,000 per annum
Job Description:
About the RoleWe are seeking an experienced Process Engineer to join our innovative MedTech company on a 12-month fixed-term contract. Specialising in cutting-edge orthopaedic products, we are at the forefront of medical device manufacturing, utilising advanced laser-based additive manufacturing technologies to deliver life-changing solutions to patients.
This is a remote position offering flexibility while working with a dedicated team committed to excellence in medical device development and manufacturing.
Key Responsibilities*Lead and support process validation activities across manufacturing operations, ensuring compliance with ISO 13485 and FDA CFR requirements
*Develop, implement, and maintain robust manufacturing processes for orthopaedic medical devices using laser-based additive manufacturing technologies
*Conduct Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971 risk management standards
*Drive continuous improvement initiatives to optimise process efficiency, quality, and compliance
*Collaborate with Quality Assurance, Regulatory Affairs, and R&D teams to ensure seamless product development and commercial manufacturing
*Prepare and maintain comprehensive process documentation, including validation protocols, reports, and standard operating procedures
*Support investigations and implement corrective and preventive actions (CAPA) for process-related non-conformances
*Ensure all processes meet stringent regulatory requirements for medical device manufacturing
Essential Experience & Skills*Validation: Proven experience in process validation (IQ/OQ/PQ) within a regulated manufacturing environment
*MedTech Regulatory Knowledge: Strong understanding of ISO 13485 Quality Management Systems
*FDA Compliance: Working knowledge of FDA Code of Federal Regulations (CFR), particularly 21 CFR Part 820
*Advanced Manufacturing: Hands-on experience with laser-based additive manufacturing processes
*Risk Management: Demonstrated expertise in PFMEA methodologies and ISO 14971 risk management
Desirable Experience*Experience with orthopaedic or implantable medical devices
*Knowledge of additional additive manufacturing technologies
*Familiarity with design controls and design history file requirements
*Experience with statistical process control and data analysis tools
This is a remote position offering flexibility while working with a dedicated team committed to excellence in medical device development and manufacturing.
Key Responsibilities*Lead and support process validation activities across manufacturing operations, ensuring compliance with ISO 13485 and FDA CFR requirements
*Develop, implement, and maintain robust manufacturing processes for orthopaedic medical devices using laser-based additive manufacturing technologies
*Conduct Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971 risk management standards
*Drive continuous improvement initiatives to optimise process efficiency, quality, and compliance
*Collaborate with Quality Assurance, Regulatory Affairs, and R&D teams to ensure seamless product development and commercial manufacturing
*Prepare and maintain comprehensive process documentation, including validation protocols, reports, and standard operating procedures
*Support investigations and implement corrective and preventive actions (CAPA) for process-related non-conformances
*Ensure all processes meet stringent regulatory requirements for medical device manufacturing
Essential Experience & Skills*Validation: Proven experience in process validation (IQ/OQ/PQ) within a regulated manufacturing environment
*MedTech Regulatory Knowledge: Strong understanding of ISO 13485 Quality Management Systems
*FDA Compliance: Working knowledge of FDA Code of Federal Regulations (CFR), particularly 21 CFR Part 820
*Advanced Manufacturing: Hands-on experience with laser-based additive manufacturing processes
*Risk Management: Demonstrated expertise in PFMEA methodologies and ISO 14971 risk management
Desirable Experience*Experience with orthopaedic or implantable medical devices
*Knowledge of additional additive manufacturing technologies
*Familiarity with design controls and design history file requirements
*Experience with statistical process control and data analysis tools
Job number 3386215
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Company Details:
Lynx Recruitment Ltd
Company size: 1–4 employees
Industry: Recruitment Consultancy
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