Manufacturing Engineer

ProVerum Ltd.; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

ProVerum Ltd. in Galway is seeking a Manufacturing Engineer to join our Operations team.

You will define, develop, and optimise manufacturing processes, own process design, tooling, and quality systems, and work cross-functionally to bring products from development to full-scale production in a regulated environment. The role focuses on process intensification, equipment qualification (IQ/OQ/PQ), validation, and continuous improvement to enhance efficiency, yield, and product quality in a

Qualifications

• Degree in mechanical, biomedical, manufacturing engineering, or related field.
• 1-3 years in a manufacturing engineering role within medical devices, life sciences, or a regulated industry.
• Working knowledge of QMS; ISO 13485, FDA 21 CFR Part 820 and Change Control preferred.

Responsibilities

• Design, develop, and qualify manufacturing processes and tooling for the ProVee system.
• Lead the installation, qualification, and routine maintenance of manufacturing equipment and production facilities.
• Identify and drive continuous improvement opportunities across production processes to enhance efficiency, yield, and quality.

Skills

Manufacturing engineering

Education

Degree in mechanical, biomedical, manufacturing engineering, or related field

Tools

SolidWorks

Microsoft Word

Microsoft Excel

Job description

ProVerum is changing how Benign Prostatic Hyperplasia (BPH) is treated, pioneering minimally invasive technology that sets a new standard of care. As we scale, we're looking for a Manufacturing Engineer to join our Operations team in Galway.

YOUR ROLE AT PROVERUM

The Manufacturing Engineer is responsible for defining, developing, and optimising manufacturing processes. Reporting to the Operations Manager, this role takes ownership of process design, tooling, quality systems. You will work cross-functionally with engineering, quality, and operations to bring products from development through to full-scale production in a regulated environment.

WHAT YOU WILL NEED

• Degree in mechanical, biomedical, manufacturing engineering, or related field
• 1-3 years in a manufacturing engineering role within medical devices, life sciences, or a regulated industry
• Working knowledge of QMS; experience with ISO 13485, FDA 21 CFR Part 820 and Change Control preferred
• Experience with equipment qualification (IQ/OQ/PQ) and process validation
• Proficiency in SolidWorks or equivalent CAD software, Microsoft Word and Excel

WHAT YOU WILL DO

Process & Tooling

• Design, develop, and qualify manufacturing processes and tooling for the ProVee system.
• Lead the installation, qualification, and routine maintenance of manufacturing equipment and production facilities.
• Identify and drive continuous improvement opportunities across production processes to enhance efficiency, yield, and quality.

Documentation & Compliance

• Author and maintain engineering drawings, manufacturing procedures, work instructions, and standard operating procedures (SOPs).
• Ensure all engineering activities are conducted in compliance with regulatory requirements (ISO 13485, FDA 21 CFR Part 820) and the company's Quality Management System.
• Support R&D transfer activities, ensuring a smooth and documented handoff to manufacturing.

Quality & Validation

• Lead or support the installation, validation, and ongoing maintenance of controlled manufacturing environments (cleanrooms, ESD zones, etc.).
• Conduct and document process validations, risk assessments (PFMEA), and non-conformance investigations.
• Collaborate with quality teams on receiving inspection protocols, in-process controls, and final acceptance criteria

WHAT WE OFFER

• Visible impact from day one: your work directly supports the devices that reach patients
• Build something lasting: join at a formative stage and develop deep SME-level expertise
• Collaborative culture: work with people who care deeply about quality and patient outcomes
• Competitive package: market salary, bonus potential, company pension, private health insurance and more