Terumo Aortic
Engineering Lead- Sterilisation
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Engineering Lead- Sterilisation
We are looking for an Engineering Lead- Sterilisation, to provide technical leadership for our Ethylene Oxide (EO) sterilisation process, ensuring it remains safe, compliant, effective, capable and well documented. This is a key technical leadership role, supporting product quality, process safety, efficiency, compliance and continuous improvement within a regulated manufacturing environment.
Working closely with the Engineering Manager, you will lead, prioritise and develop a small engineering team, translating business priorities into clear team plans, objectives and deliverables. You will also act as the subject matter expert for EO sterilisation, supporting process control, troubleshooting, investigations, CAPA, change control, validation, revalidation and continuous improvement activities.
This is a fantastic opportunity to work with a great team, enjoy excellent career development and truly make a difference.
Key responsibilities
- Provide technical leadership for the EO sterilisation process, ensuring compliance with applicable regulatory requirements, quality standards and internal procedures.
- Lead, coach and develop a small technical engineering team, supporting workload prioritisation, capability development, training progression and delivery of agreed objectives.
- Translate Engineering Manager direction into clear team priorities, workload plans and deliverables.
- Set monthly priorities with team members and host regular one-to-ones and team meetings to review progress, risks, development needs and escalation points.
- Act as SME for EO sterilisation, providing technical support across process control, troubleshooting, investigations, CAPA, change control and validation/revalidation activities.
- Work cross-functionally with Quality, Operations, EH&S, Validation, Maintenance, Sterility Assurance/Microbiology and other stakeholders to ensure EO process risks and priorities are effectively managed.
- Identify opportunities to improve safety, quality, efficiency, compliance and cost within the sterilisation process.
- Escalate technical, quality, safety, capacity or resource risks in a timely and appropriate manner.
- Support a strong safety culture, ensuring EO-related hazards, risk assessments, exposure prevention measures and emergency arrangements are understood, documented and managed effectively.
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About You
We are looking for someone with strong technical knowledge, leadership capability and experience working within a regulated manufacturing environment. You will be confident working cross-functionally, able to manage competing priorities and comfortable providing technical guidance on EO sterilisation activities.
- A Bachelor’s degree or equivalent in engineering, science or a related technical discipline.
- Sterilisation experience gained within a scientific or regulated environment, with demonstrable knowledge of EO sterilisation, sterilisation validation, process control or sterility assurance principles.
- Solid manufacturing engineering experience, ideally within medical devices or a similarly regulated manufacturing environment.
- Experience leading or supervising technical personnel, including workload prioritisation, coaching, competency development and performance input.
- Experience working within medical device quality systems, including investigations, CAPA, change control, validation and technical documentation.
- Strong interpersonal, planning, organisational, communication and stakeholder management skills.
- Strong project management experience, computer skills and industry knowledge.
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Desirable experience
- Knowledge of Lean manufacturing principles such as SMED, visual management and 5S.
- Six Sigma certification, with Black Belt desirable, although Green Belt would also be suitable.
Why apply?
This is an excellent opportunity for an experienced sterilisation or manufacturing engineering professional to step into a highly visible technical leadership role. You will have the opportunity to influence a critical process, support compliance and safety objectives, develop a team and contribute to continuous improvement within a regulated manufacturing environment.
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