Principal Manufacturing Engineer

Principal Manufacturing Engineer (m/f/d) Galway

We are LUMA Vision, a start-up based in Dublin (Ireland) and Munich (Germany) developing cutting-edge innovative imaging technologies to significantly advance healthcare and address global unmet clinical needs. We apply our engineering and design expertise to create new hardware, software, and data science technologies. To support our Manufacturing function, we are seeking a Principal Manufacturing Engineer to join our growing team. This role requires on-site work with our supplier in West Ireland up to 3 days per week.

Your role will be

The Principal Manufacturing Engineer leads the technical delivery of Manufacturing Engineering activities within LUMA Vision, including at contract manufacturing suppliers and distribution centers. You will ensure successful project completion, meet production goals, ensure compliance with standards and regulations, operate cost-effectively, and drive continuous improvement initiatives. Collaboration with stakeholders and suppliers to plan and execute projects to meet production performance requirements is essential.

What you offer

- Technical leadership in manufacturing transfer & ramp-up of new and existing products, supporting successful transition to manufacturing using design for manufacturability principles.
- Development and implementation of manufacturing capabilities using LEAN principles and tools such as Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis, and Line Balancing.
- Experience working with Quality Assurance, managing NCMRs and CAPAs, monitoring suppliers, conducting audits, risk management, and ensuring compliance with ISO 13485 and other relevant standards for medical devices and pharmaceuticals.
- Contribution to departmental and company goals.
- Regular updates and communication with stakeholders regarding project status and objectives, aligning with cross-functional business goals.
- Providing technical leadership for manufacturing and distribution channels at an international level.
- Development and execution of manufacturing timelines aligned with project and regulatory requirements.
- Financial modeling for COGS and scaling production capacity.
- Technology transfer to manufacturing partners or contract organizations.
- Promotion of continuous improvement culture and cost-saving initiatives.
- Creation and management of the annual manufacturing project budget.
- Demonstrating integrity, vision, and knowledge within the organization.

Experience

- Bachelor's degree in engineering or related field with at least 10 years' experience, including 5 years in a technical leadership role within the medical device industry.
- Experience with ISO 13485/FDA regulated quality systems and risk management methodologies.
- Proven track record in manufacturing and process development in a regulated environment; experience with medical device catheters is a plus.
- Ability to achieve results within a co-located organization and work effectively with cross-functional teams.
- Passion for engineering principles and concepts, with a keen interest in how and why things work.
- Knowledge in DFM, technology evaluation, process design, materials, Six Sigma, CAD (preferably SolidWorks), statistical techniques, process validation, and manufacturing KPIs.
- Excellent analytical, decision-making, organizational, communication, and leadership skills.
- Ability to manage consultants, suppliers, vendors, and budgets efficiently.
- Capability to thrive in a fast-paced, high-growth environment, managing multiple tasks with high quality.

What we offer

- Opportunity to work on cutting-edge imaging systems that benefit patients and improve healthcare.
- Part of a dynamic, multinational team with a strong focus on culture and individual development.
- A learning environment to expand your skills and interests.
- Flexible working arrangements, international culture, and offices in Germany and Ireland.

LUMA Vision is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, disability, religion/belief, sexual orientation, or age.

If you're interested in joining our team, we look forward to receiving your CV and cover letter. Please apply at [emailprotected].

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