We’re looking for a hands‑on Technical Process Development Engineer to develop, install and validate robust manufacturing processes that consistently meet Product, Customer, Regulatory and Quality requirements. You’ll combine deep problem‑solving with structured validation and continuous improvement to raise process capability, unlock cost savings, and support safe, compliant, right‑first‑time manufacturing.

What you’ll do

Process development & validation

• Develop, install and validate new/updated processes and equipment for product manufacture.
• Deliver stable, capable and well‑documented processes (incl. SOPs, WIs, procedures).
• Plan, compile and execute process validation strategies (protocols, reports, IQ/OQ/PQ), confirming output “fit & function”.
• Apply FMEA and DOE to characterise risk, optimise parameters and lock in control plans.
• Generate drawings where required and review/approve production artwork.

Continuous improvement & cost optimisation

• Continually review manufacturing processes to measure, refine and improve capability and effectiveness.
• Identify and deliver structure CI programmes (e.g., SMED, visual management, 5S) to achieve cost, quality and throughput targets.
• Identify material/process cost‑saving opportunities; plan and execute trials, validate changes, document and release.

Cross‑functional collaboration & technology transfer

• Support site investment programmes and introduce new/modified equipment and methods.
• Liaise with internal stakeholders and external suppliers; ensure specifications and packaging materials are available for transfer to manufacture.
• Assess and facilitate transfer of product manufacture (intercompany and to contract manufacturers), sharing process knowledge and documentation.

Quality, compliance & problem solving

• Ensure appropriate testing and validation is performed on materials and processes; verify product “fit & function”.
• Lead/participate in root‑cause investigations; analyse/approve corrective actions and monitor field response for effectiveness.
• Support QS audits in manufacturing; act on findings and contribute to Quality System development aligned to ISO 13485:2016.
• Provide quality data/reports/charts for manufacturing and supplier performance; generate required documentation for regulatory updates/findings.
• Work within the QMS at all times, keep accurate records, and maintain an audit‑ready state.

Leadership & ways of working

• Supervise assigned engineers/technicians; allocate tasks, coach, and ensure delivery to agreed timescales.
• Create a safe working environment and drive EHS goals: complete risk assessments, raise/action hazards, and promote a strong safety culture.

What you’ll bring

Qualifications & experience

• Minimum HND (or equivalent) in a relevant engineering discipline.
• Solid manufacturing engineering experience in a high‑quality, regulated environment (medical devices experience advantageous).
• Proven project management experience delivering equipment/process introductions and validations.

Technical skills

• Strong knowledge of process design, engineering and maintenance.
• Practical experience creating process solutions (jigs, fixtures, tooling, process equipment & machinery).
• Proficient with FMEA, DOE and statistical methods for process characterisation and optimisation.
• Desirable: automated processes, vision inspection systems, co‑bots/robotics; Lean methods (SMED, VM, 5S).
• Strong computer literacy and industry systems know‑how (e.g., drawings/PLM/validation documentation).