Instrument Manufacturing Engineer in Caernarfon

Join our team now at Siemens Healthineers as Instrument Manufacturing Engineer within the Specialty Lab Diagnostics business line at our facility in Llanberis. This role supports a crucial strategic project for the SLS business line and Llanberis, overseeing the manufacture of the IMMULITE XPi and Versacell instruments and spares, ensuring high-quality standards, efficiency, and regulatory compliance. The role involves process optimisation, troubleshooting, and continuous improvement in partnership with R&D, with best practices in process design and manufacturing flow to enable a smooth ramp up and development of a world-class manufacturing operation in Llanberis. The role typically operates Monday to Friday, 8:30am to 4:30pm.

Responsibilities

• Engineering Change Management: Lead and coordinate the implementation of engineering changes across manufacturing processes; review and validate change requests for feasibility and manufacturability; develop and maintain documentation for all changes, including work instructions, process flows, and BOM updates.
• Regulatory & Quality Compliance: Ensure all changes comply with regulatory standards and internal quality control procedures; support validation activities (IQ/OQ/PQ) for process or equipment changes; maintain traceability and documentation for audits and regulatory submissions.
• Cross-Functional Collaboration: Work with R&D, Quality Assurance, Supply Chain, and Production teams to ensure smooth implementation; communicate risks, timelines, and mitigation plans to stakeholders.
• Process Optimization: Identify opportunities for lean improvements during change implementation; support continuous improvement initiatives to reduce waste and improve efficiency.
• Training & Support: Provide training to operators and technicians on updated processes or equipment introduced through changes.

Qualifications

• Curious and eager to learn, with excellent written and oral communication skills.
• Ability to read and interpret technical drawings, schematics, and specifications.
• Proficiency with testing equipment and tools to optimise and improve mechanical and electrical assembly processes.
• Excellent attention to detail and organisational skills.
• Ability to work independently and manage multiple tasks; able to work in a fast-paced, dynamic environment.
• GDP & GMP (Good Documentation Practices & Good Manufacturing Practices).
• Bachelor's degree in Manufacturing Engineering, Mechanical, Electrical or Electronic Engineering, or a related field.
• Minimum of 3 years or equivalent experience in a manufacturing engineering role.
• Strong knowledge of manufacturing processes and quality control systems.
• Proficiency in statistical process control (SPC) and Six Sigma methodologies.
• Experience with regulatory compliance (e.g., FDA, ISO) in a manufacturing environment.
• Excellent problem-solving and analytical skills.
• Familiarity with Lean Manufacturing principles.

Benefits

• 26 days' holiday with the option to buy or sell an additional 5 days.
• Up to 10% employer pension contribution.
• Share and bonus scheme.
• Access to flexible benefits including private medical insurance and dental cover.
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and access to our 24/7 employee assistance programme.