Based on the provided information, here’s a structured job description for the Operations & Service Engineer (m/f/d) position at LUMA Vision:

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

Location: Massachusetts, USA
Company: LUMA Vision
Employment Type: Full-Time
Industry: Medical Devices / Healthcare Technology(Weekday, Illuminating Engineering Society, HRBlade)

Company Overview

LUMA Vision is a pioneering start-up headquartered in Dublin, Ireland, with an additional base in Munich, Germany. We specialize in developing cutting-edge imaging technologies aimed at addressing significant unmet clinical needs globally. Our multidisciplinary team leverages expertise in engineering, design, and data science to create innovative hardware and software solutions that advance healthcare.

Position Summary

We are seeking an experienced and dynamic Operations & Service Engineer to lead our hardware manufacturing servicing activities. This role encompasses technical leadership across contract manufacturing suppliers, distribution centers, and field locations. The ideal candidate will ensure the successful delivery of product hardware asset management activities, compliance with applicable standards and regulations, and the continuous improvement of manufacturing performance.

Key Responsibilities

• Lead the manufacturing transfer and ramp-up of new products, incorporating design for manufacturability principles.
• Develop and implement field service capabilities, including installation, servicing, and repair of products at clinical sites and third-party repair locations, in collaboration with the Clinical Commercial team.
• Manage quality aspects such as Non-Conformance Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs), supplier monitoring, audits, risk management, and internal controls, ensuring compliance with ISO 13485 and relevant medical device regulations.
• Contribute to departmental and company goals, providing regular updates and recommendations to stakeholders on objectives, projects, and cross-functional business objectives.
• Provide technical leadership to support business partners in executing projects aligned with long-term manufacturing and field service plans.
• Facilitate technology transfer to partner or contract organizations as applicable.
• Promote a culture of continuous improvement and drive cost-saving initiatives.
• Create and manage the annual budget for manufacturing service activities.
• Demonstrate strong integrity, vision, and technical aptitude within the organization.

Qualifications and Experience

• Bachelor’s degree in Engineering or a related field.
• Minimum of 10 years of experience in the medical device industry, with at least 5 years in a technical leadership role.
• Proficient in ISO 13485/FDA regulated quality systems, with a solid understanding of risk management methodologies.
• Proven track record in manufacturing and field service within a regulated environment; experience with catheter products is a plus.
• Ability to achieve results in a virtual organization and work effectively with cross-functional teams.
• Expertise in manufacturing service knowledge, including design for manufacturability (DFM), process design and development, statistical techniques, process validation, and electro-mechanical service repair.
• Excellent analytical, decision-making, organizational, communication, interpersonal, managerial, and leadership skills.
• Capability to manage consultants, suppliers, vendors, and budgets effectively.
• Adaptability to work in a fast-paced, high-growth environment, handling multiple tasks with high quality to meet business timelines.(Monster.com)

What We Offer

• Opportunity to work with a passionate and innovative team dedicated to advancing healthcare technology.
• Engagement in projects that have a meaningful impact on global health.
• Collaborative work environment with cross-functional teams.
• Competitive compensation and benefits package.

Application Process: Interested candidates are encouraged to apply through our official job posting.