Instrument Manufacturing Engineer

Siemens Healthineers; Caernarfon; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading medical technology firm in Caernarfon is seeking an Instrument Manufacturing Engineer to develop and implement manufacturing processes for their diagnostic instruments. The successful candidate will have a Bachelor's degree in Engineering and a minimum of 3 years’ experience in manufacturing engineering, preferably within medical devices. This position involves ensuring compliance with high-quality standards and regulatory requirements while collaborating with cross-functional teams. The role offers a competitive salary and comprehensive benefits.

Benefits

26 days holiday with options to buy/sell days

Up to 10% employer pension contribution

Share and bonus scheme

Flexible benefits including private medical insurance

Paid volunteering days

Qualifications

• Minimum of 3 years experience in a manufacturing engineering role.
• Strong knowledge of regulatory compliance (e.g., FDA, ISO).
• Ability to read technical drawings and schematics.

Responsibilities

• Develop manufacturing processes for IMMULITE XPi and Versacell instruments.
• Conduct process capability studies and ensure Six Sigma compliance.
• Troubleshoot production issues and implement corrective actions.

Skills

Manufacturing processes knowledge

Quality control systems

Statistical process control

Problem-solving skills

Lean Manufacturing principles

Communication skills

Education

Bachelor’s degree in Engineering

Job description

Responsibilities

• Develop and implement manufacturing processes for the IMMULITE XPi and Versacell instruments.
• Provide input to the process for control and disposition of any non‑conforming materials, completing tasks, documentation, and segregating materials as required within the QMS.
• Conduct process capability studies and ensure processes meet Six Sigma quality standards.
• Troubleshoot production issues and implement corrective actions.
• Lead fault‑finding and diagnosis of legacy PCBAs to component level.
• Collaborate with cross‑functional teams to optimise production workflows.
• Ensure compliance with regulatory standards and internal quality control procedures.
• Perform regular audits and inspections of manufacturing processes.
• Manage and analyse production data to identify trends and areas for improvement.
• Provide technical support and training to production staff.
• Manage revision controls and IED updates.
• Participate in product development and scale‑up activities working with R&D.
• Specify and select components and suppliers suitable for our applications, taking account of performance, reliability, quality, cost and obsolescence.
• Share knowledge, support other engineers, lead design reviews and work within R&D, engineering, and project processes.
• Effectively communicate with internal and external suppliers/stakeholders.
• Provide support for both internal and third‑party site audits.
• Participate in TS5QDIP meetings, provide accurate and timely reports, and take ownership for the achievement of target KPI’s and operational performance for the role.
• Ensure compliance with QMS and all safety, health and environmental legislation.

Qualifications

• Bachelor’s degree in Manufacturing Engineering, Mechanical, Electrical or Electronic Engineering, or a related field.
• Minimum of 3 years or equivalent time served experience in a manufacturing engineering role, preferably in medical devices and/or electronic manufacturing.
• 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.
• 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.
• Knowledge of Product Safety Directives, such as the machinery and low‑voltage equipment directives, and understanding of the steps required to lead design reviews and demonstrate product compliance.
• Excellent written and oral communication skills and attention to detail.
• Ability to work independently and manage multiple tasks simultaneously in a fast‑paced, dynamic environment.
• Knowledge of GDP & GMP (Good Documentation Practices & Good Manufacturing Practices).

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 from private medical insurance to dental cover.
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year.
• Support from our 24/7 employee assistance programme.

How we work

When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals and skilled specialists who believe in each individual's potential to contribute with diverse ideas. We come from different backgrounds, cultures, religions, political and/or sexual orientations, and work together to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone, everywhere, sustainably.

Equal Opportunity

As an equal opportunity employer, we welcome applications from individuals with disabilities. Siemens Healthineers are proud to be a Disability Confident Committed employer. If you require any adjustments at any stage of the recruitment process, please let us know.

Privacy

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To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus recommend you refrain from any such practices. Your adherence to our policies is appreciated.

Join our team now at Siemens Healthineers as Instrument Manufacturing Engineer within the Specialty Lab Diagnostics business line at our facility in Llanberis. This is a great opportunity to join and support the delivery of a crucial strategic project for our SLS business line and Llanberis.

Key responsibilities include overseeing the effective manufacture of the IMMULITE XPi, Versacell instruments along with spares, ensuring high‑quality standards, efficiency, and compliance with regulatory requirements. The role involves process optimisation, troubleshooting, continuous improvement initiatives along with process updates in partnership with R&D.

You will work in partnership with the existing instrument knowledge transfer team to develop best practices in process design, and manufacturing flow to ensure a smooth manufacturing ramp‑up and the subsequent development of a world class manufacturing operation in our Llanberis facility.

This role will work Monday to Friday, 8:30 am to 4:30 pm.

You will be curious, keen to understand, learn and try new things, and possess excellent written and oral communication skills. You’ll have the ability to read and interpret technical drawings, schematics, and specifications and to work independently and manage multiple tasks simultaneously in a fast‑paced, dynamic environment.

We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing.