Operations + Service Engineer

Operations + Service Engineer (m/f/d) USA

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 hardware, we are seeking an Operations & Service Engineer to join our growing team. This role requires on-site work at our Manufacturing and Field locations as needed.

Your role will be

The Operations & Service Engineer will lead hardware manufacturing and servicing activities at LUMA Vision, including coordination with contract manufacturing suppliers, distribution centers, and field operations. You will ensure the successful delivery of product and hardware asset management activities, compliance with standards and regulations, world-class manufacturing performance, cost efficiency, and continuous improvement initiatives. Collaboration with stakeholders and suppliers will be essential to ensure hardware availability for clinical use through project execution and ongoing manufacturing and service activities.

What you offer

- Technical leadership in manufacturing transfer and ramp-up of new and existing products, supporting manufacturing transitions using design for manufacturability principles.
- Development and implementation of field service capabilities, including installation, servicing, and repair of LUMA Vision products onsite at clinical sites and third-party repair centers, in collaboration with the Clinical & Commercial teams.
- Management of quality processes, including NCMRs, CAPAs, supplier monitoring, audits, risk management, and internal controls, ensuring compliance with ISO 13485 and other relevant standards for medical devices.
- Contribution to departmental and company goals, with regular updates to stakeholders on project status and alignment with cross-functional objectives.
- Support for business partners through technical leadership and project execution to fulfill long-term manufacturing and service plans.
- Technology transfer to partners or contract organizations as applicable.
- Promotion of continuous improvement culture and cost-saving initiatives.
- Creation and management of annual budgets for manufacturing and service activities.
- Demonstration of integrity, vision, knowledge, and overall organizational aptitude.

Experience

- Bachelor’s degree in engineering or related field, with at least 10 years of experience, including 5 years in a technical leadership role within the medical device industry.
- Experience working within ISO 13485/FDA regulated quality systems, with understanding of risk management methodologies.
- Proven track record in manufacturing and field service in a regulated environment; experience with medical device catheter products is a plus.
- Ability to work effectively in a virtual organization, with cross-functional teams, project facilitation, and on-time project completion.
- Passion for engineering principles and concepts—someone who enjoys understanding how and why things work.
- Knowledge and skills in manufacturing & service areas such as DFM, process design, statistical techniques, process validation, and electro-mechanical repair.
- Excellent analytical, decision-making, organizational, communication, interpersonal, managerial, and leadership skills.
- Ability to manage consultants, suppliers, vendors, and budgets efficiently.
- Ability 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 focused on culture and individual development.
- A learning environment to enhance and expand your skills and interests.
- Flexible working environment, 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 are interested in joining our team, we look forward to receiving your CV and cover letter. Please apply for the position at [emailprotected]

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