Operations & Service Engineer (m/f/d) – USA (Remote)

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Hello and welcome. If you’re an experienced engineering leader seeking a meaningful role with a dynamic startup, you’ve come to the right place. LUMA Vision—a medical imaging innovator—has an opening for an Operations & Service Engineer in the USA. Read on for a complete overview of the role, responsibilities, qualifications, benefits, and application details

Job Overview

  • Position Title: Operations & Service Engineer (m/f/d) – USA

  • Company: LUMA Vision

  • Location: USA – on-site at manufacturing and field sites as needed

  • Employment Type: Full-time, remote/field hybrid

  • Company Profile: LUMA Vision is a venture-backed startup located in Dublin and Munich, developing advanced imaging technologies to improve global healthcare outcomes 

Role & Responsibilities

In this position, you will:

  1. Provide technical leadership for hardware manufacturing and service projects at contract manufacturing sites, distribution centers, and clinical field locations

  2. Ensure hardware readiness for clinical use, including project execution and ongoing servicing

  3. Lead new product manufacturing transfers and ramp-up activities, applying design-for-manufacturability principles

  4. Develop, implement, and support field service operations—installation, repair, and maintenance—at clinical sites and third-party locations

  5. Collaborate with Quality teams to manage NCMRs, CAPAs, supplier audits, internal controls, and maintain compliance with ISO 13485 

  6. Drive continuous improvement and cost-saving initiatives across manufacturing and service processes

  7. Coordinate and report on project status, goals, and cross-functional activities to stakeholders

  8. Manage annual budgets, vendors, consultants, and project timelines with precision 

Required Qualifications

The ideal candidate will have:

  • A Bachelor’s degree in Engineering or a related field

  • At least 10 years of experience in the medical device industry, with a minimum of 5 years in a technical leadership role

  • Deep familiarity with ISO 13485 and FDA-regulated quality frameworks, including risk management, NCMRs, CAPAs, audits

  • A strong background in manufacturing and field service of regulated medical hardware—experience with catheter or imaging systems is advantageous

  • Expertise in design-for-manufacturability, process validation, statistical process control, and electro-mechanical repairs

  • Excellent analytics, decision-making, negotiation, organizational, and leadership skills

  • Proven ability to work in fast-paced, high-growth, and virtual environments while managing multiple tasks and priorities

Benefits & Work Culture

Candidates for this role can expect:

  • The chance to work on pioneering imaging technology that directly benefits patients and healthcare providers

  • Engagement with a diverse, international team focused on individual growth An enriching learning environment with exposure to cutting-edge engineering projects

  • Flexible working options aligned with an international workplace culture and locations in Germany and Ireland 

  • A supportive, development-oriented organizational ethos grounded in innovation, inclusion, and integrity.

Why This Role Matters

This position offers a unique intersection of:

  • Technical leadership in both manufacturing and field environments

  • Regulatory expertise within a highly regulated biomedical field

  • Cross-functional collaboration spanning engineering, quality, supply chain, and clinical teams

  • Strategic impact in rolling out new products and sustaining service excellence

  • Career growth within a mission-driven startup focused on transforming patient care.

Application Process

LUMA Vision invites candidates to submit a resume and cover letter outlining:

  • Leadership roles in manufacturing or field service of medical devices

  • Experience with ISO 13485 systems and risk-based methodologies

  • Success in continuous improvement, budget handling, and technical team leadership

Please address applications to the provided company email.

Final Thoughts

If you’re a seasoned engineering professional eager to take on a technical leadership role in medical imaging, this is a powerful chance to influence patient-centered innovation at LUMA Vision. With remote flexibility, manufacturing and field impact, and a global, growth-focused environment, this opportunity may be the perfect next step for your career.

Best wishes with your application.

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