WHO ARE WE?

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 solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design knowhow to create new hardware, software and data science technologies.  To support our hardware we are looking for an Operations & Service Engineer to join our growing team.  This role will require the right person to work on-site at both our Manufacturing and Field locations as required.

Your role will be

The Operations & Service Engineer is responsible for technical leadership of Hardware Manufacturing & Servicing activities within LUMA Vision, including activities at contract manufacturing suppliers, distribution centres & field. You will ensure successful delivery of product & hardware asset management activities to meet company goals; ensuring compliance to applicable standards and regulations; ensuring world-class manufacturing performance; operating cost-effectively; and identifying areas & driving delivery of projects to achieve continuous improvement. You will collaborate with stakeholders and suppliers to ensure Hardware availability for Clinical Use through execution of project activity and ongoing manufacturing & service activity.

What you offer

• Technical leadership of the manufacturing transfer & ramp of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts, as applicable.
• Develop and Implement field service capabilities for Luma Vision products along with install, service and repair of this product both onsite at Clinical Sites and at 3rd Party repair locations in conjunction with the Clinical & Commercial team.
• Responsible for working with Quality including management of NCMR’s and CAPA’s, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device products.
• Contribute to the successful execution of departmental and company goals.
• Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
• Support business partners by providing technical leadership and driving exection of projects to deliver company’s long-term manufacturing and field service plans.
• Technology transfer to partner or contract organizations, as applicable
• Promote and support a continuous improvement culture and drives cost saving initiatives.
• Create and manage annual budget for Manufacturing & Service activities.
• Provide strong integrity, vision, knowledge, and overall aptitude to the organization.

EXPERIENCE

• Bachelor’s degree in engineering or related specialty with a minimum of 10 years’ experience with at least 5 years in a technical leadership role in the medical device industry.
• Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodology
• A proven track record in manufacturing and field service in a regulated environment. Medical device catheter product experience a plus.
• Ability to achieve results in a virtual organisation. Experience working with cross-functional teams, project facilitation and demonstrated ability to complete projects on time.
• This role is primarily technical in nature; thus, we seek someone who is passionate about Engineering concepts and principles – someone who gets a thrill from how and why things work
• A seasoned professional in Manufacturing & Service knowledge and skills in some or all of the following: DFM, process design and development, statistical techniques, process validation, electro-mechanical service & repair
• Excellent analytical and decision-making skills
• Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions
• Strong organizational, communication, interpersonal, managerial and leadership skills
• Ability to effectively and efficiently manage consultants, suppliers, vendors and budgets.
• Ability to work in a fast paced, high growth environment. Ability to handle multiple tasks with high quality to meet Business t

WHAT WE OFFER

• Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
• Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
• A learning environment where you can extend and build upon your skills and interests.
• Flexible working environment and an international culture as well as 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.

Would you like to become part of our team?

We would love to hear from you and look forward to receiving your CV and cover letter.  Please apply for the position at  [email protected]