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Senior Design Assurance Engineer

Galway, Ireland

QA/RA

Shape the Face of Cancer Treatment at Luminate Medical

Luminate Medical is on a mission to change the way we experience cancer care. We design and build products which revolutionise the patient experience of healthcare and radically improve quality of life. Our first product is a wearable medical device to prevent the hair loss caused by cancer chemotherapy. Luminate’s Lily Device is a portable, comfortable, and more effective solution to preventing chemotherapy induced hair loss than the current standard.

 

Delivering this vision and product hinges on having a great Regulatory and Quality function. This means building regulatory strategies that efficiently bridge the gap between innovation and real patient impact. Implementing quality management processes that ensure an empowering experience for every patient. Driving regulatory clearance so that patients can finally have access to the products that solve the needs that matter to them.

 

We’re looking for a Senior Design and Quality Assurance Engineer to lead Quality Engineering support for all phases of the product development process. You will take the lead on the implementation of a Quality Management System in compliance with ISO 13485 by writing new Quality Management processes. You'll lead risk management activities within the product development cycle, working actively to mitigate product risks. You will develop new test methods to ensure risks are analysed and report on data gathered to support regulatory compliance.

 

This position requires a collaborative, high-energy personality who can drive risk management and Quality System implementation as the company develops towards US market launch in 2023. The ideal candidate will be comfortable working cross-functionally between RA/QA and R&D, and have deep knowledge of ISO 13485 and IS0 14971. Above all, you will need a passion to find creative solutions that ensure risks are addressed in a timely fashion, ensuring benchtop innovations are safely translated into real patient impact.

Working at Luminate Medical

  • This is a key early hire at a rapidly growing company. You will have an opportunity to shape the development of a high-impact patient-facing product and gain first-hand insights into the growth of a start-up.

  • We offer a highly competitive salary comparable with multinational medical device companies (available on application) and company stock compensation.

  • We believe in quality of life in our product and for our people, offering a flexible benefit scheme, flexible working hours, work-from-home options, and a generous vacation policy.

What You Will Do:

  • Work collaboratively to drive patient-focused cancer care products from idea to manufacture by leading Design Assurance activities as part of an overall Product Development team, including:

    • Leading risk management activities, including developing risk management documentation to US FDA and EU MDR requirements and ensuring appropriate verification and validation testing against product risks.

    • Writing test method validations, design verification and shelf-life protocols, and test reports.

    • Creating design solutions to reduce product risks and ensure compliance with regulations and standards.

    • Work closely with R&D team members to communicate ISO standard and regulatory requirements, influencing design direction.

  • Lead the implementation of a Quality Management System, including:

    • Support the development of a functional QMS, suited to the company’s needs.

    • Supplier selection and management.

    • Educate team members on how to comply with Quality Management processes.

    • Maintain expert, up to date knowledge of developments in regulatory compliance.

  • Take responsibility for the delivery of project goals in a timely fashion by working closely with, guiding, and building relationships with external suppliers and manufacturing partners, managing their time effectively and maintaining agreed timeline.

 

Personal Attributes – The Ideal Candidate Is:

  • A creative problem solver who is enthusiastic about new ideas and eager to bring innovative products to market as quickly as possible.

  • A proactive team player. You seek to learn from colleagues and help develop your teammates.

  • Resourceful, independent, and self-motivated with a hands-on attitude.

  • Outstanding in written and verbal communication and collaboration skills. You are able to articulate ideas clearly and support ideas with evidence.

Experience Requirements – The Ideal Candidate Must Have:

  • 5+ years of experience in Design and/or Quality Assurance (preferably in a medical device environment).

  • A primary degree in Engineering or Quality Assurance, or equivalent experience.

  • Experience with directly creating and managing Design History File documents such as Risk Management, Design Inputs, Test Method Design and Validation, and Design Verification Plans alongside experience writing formal testing protocols and test reports.

  • A strong understanding of medical device regulatory requirements and applicable standards, in particular FDA guidance, MDR guidance, ISO 13485, ISO 14971.

  • Strong technical writing and communication skills.

Experience Advantages – It Would be Advantageous to Have:

  • Previous experience working with Class II electromechanical medical devices.

  • Lead auditor training.

  • Experience working with IEC 60601.

Senior Design Assurance Engineer
Application Form

Have questions about this role? Email us at founders@luminatemed.com.

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