Job Description
About the Role
We are seeking an experienced Process Engineer to join our innovative MedTech company for an exciting contract opportunity. 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 12-month contract role offers the perfect opportunity to make an immediate impact in a fast-paced, innovative environment while gaining valuable experience in advanced additive manufacturing and regulatory compliance.
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
