PDE/NPI Engineer
Job Specification: NPI / Process Engineer (Process Owner - Medical Devices)
Role Overview
We are seeking an experienced NPI Engineer / Process Engineer to act as the Process Owner for a defined manufacturing process within our medical device production environment. This role is responsible for developing, owning, and continuously improving the manufacturing process, ensuring high levels of quality, reliability, and operational performance.
Key Responsibilities
- Process Ownership:
- Serve as the technical owner for an assigned manufacturing process.
- Maintain deep understanding of process capability, performance trends, and risk areas.
- Lead process governance, documentation, and change control.
- Process Engineering & Support:
- Provide day‑to‑day technical support to the manufacturing line.
- Troubleshoot process issues quickly and effectively to minimise downtime.
- Conduct root‑cause analysis and implement corrective and preventive actions (CAPA).
- New Product Introduction (NPI):
- Support or lead introduction of new products or process changes into manufacturing.
- Develop and validate processes, equipment, tools, and methods.
- Ensure successful handover of new processes into steady‑state production.
- Continuous Improvement:
- Identify opportunities to improve yield, throughput, quality, and cost.
- Drive process optimisation initiatives based on data analysis and engineering principles.
- Maintain process documentation, standard operating procedures, and technical specifications.
- Cross‑Functional Collaboration:
- Work closely with Quality, Manufacturing, R&D, and Equipment Engineering teams.
- Represent the process in audits, reviews, and technical discussions.
- Ensure compliance with regulatory and quality standards for medical devices.
Required Experience & Skills
- Proven experience in Manufacturing Process Engineering, ideally within medical devices or other regulated industries.
- Strong background in supporting and improving processes on a live manufacturing line.
- Demonstrated ability to act as a process owner, with accountability for process performance.
- Excellent problem‑solving, technical troubleshooting, and root‑cause analysis capabilities.
- Experience with NPI, process validation (IQ/OQ/PQ), and process documentation.
- Understanding of quality systems and regulatory guidelines (e.g., ISO 13485).
FAQs
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