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Senior R&D Validation & Verification Engineer

Luminate Medical

Luminate Medical

Galway, Ireland
Posted on Monday, March 25, 2024

Shape the Face of Cancer Treatment at Luminate Medical

At Luminate, we build products that help cancer patients to live, not just survive. Our mission is to build technologies that help oncologists make cancer care better, faster, and safer for patients. Our first two products, Lily and Lilac, are revolutionary wearable devices designed to address hair loss and peripheral neuropathy respectively – two of the most common and difficult side effects of cancer treatment.

We’re looking for a Senior R&D Validation & Verification Engineer to become the next key player in our R&D team. You will be a leading contributor to our fast-moving and growing product design and engineering team. You will lead the test method development and test method validation activities related to the medical devices under development. This includes verifying or validating applications, automated test methods, manual test methods as well as performance and other test methods.

The ideal candidate will be familiar with test method design and validation. You should have a strong knowledge of attribute and variable test methodologies and be able to apply methods such as MSA, TVM, Gage R&R, DOE etc. This person will have deep knowledge of sample size, test method, conditioning and tools needed for the tests. The ideal candidate should have a good mix of design skills, analytical skills, engineering skills and IT skills.

In parallel, you will need a passion to find creative and patient-focused solutions to complex design challenges and enjoy working in a fast-paced environment.

Working at Luminate Medical

  • This is a key hire at a rapidly growing company. You will have an opportunity to shape the development of multiple high-impact patient-facing products 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), a flexible benefits package (including health insurance and pension), alongside a company laptop, headphones and camera.
  • We believe in quality of life in our products and for our people, offering flexible working hours, healthcare and vacation policy.

What You Will Do:

  • Drive the test method validation of patient-focused cancer care products, including:
  • Creating and developing robust test methods (for an electro-mechanical device) that ensure the product is adequately challenged in alignment with Design Control and Process requirements.
  • Generate test method master validation plans, generate test method validation protocols and reports.
  • Be able to generate robust rationales for using verification methodologies or justifying where validation is not required. Be able to justify deviations from protocol execution.
  • Generating new design ideas and concepts that meet the overarching design requirements.
  • Communicating design decisions, interpreting literature and test results, and influencing design direction.
  • Exploring and vetting materials, components and suppliers.
  • Ensuring the patient is at the center of the design by working closely with clinical and marketing to define the product user needs.
  • Defining design requirements from high level user needs specifications.
  • Leading the completion of tasks and projects through a methodological and planned approach to product development.
  • Testing, analysis and development of design concepts for novel medical devices through:
  • Support R&D activities as required.
  • Lead the delivery of projects 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 timelines.

Personal Attributes – The Ideal Candidate Is:

  • Creative: A creative problem solver who is enthusiastic about new ideas.
  • Open: A proactive team player who seeks to help develop your teammates. You are willing to adopt, engage with and shape company culture in a positive manner. You can give and receive candid feedback in a constructive and positive manner.
  • Communicative: Outstanding in written and verbal communication and collaboration skills. You are able to articulate ideas clearly and support ideas with evidence.
  • Self-Driven: You have a sense of urgency in your work, are resourceful and independent, and thrive when taking responsibility for tasks.
  • Organised: You can prioritise your list of tasks independently and ensure actions are completed on time.

Experience Requirements – The Ideal Candidate Must Have:

  • Test Method Validation Experience: Worked on several design projects, 4+ years of experience, ideally leading verification/validation activities. We would prefer medical device experience but are interested in meeting candidates with alternative experience around consumer products.
  • Testing: Clear ability to create robust tests of design concepts, predict outcomes and determine iteration requirements.
  • Prototyping: Comfortable with rapid prototyping using FDM, SLS and SLA 3D printing. Can demonstrate understanding of the limitations of rapid prototyping and experienced in using machined prototypes. Good benchtop skills for manufacturing prototypes.
  • Manufacturing: Demonstrable examples of design for assembly/manufacture experience.

Experience Advantages – It Would Be Advantageous to Have:

  • Knowledge of validating plastics forming techniques such as dip moulding, blow moulding and thermoforming.
  • Experience with directly creating Design History File documents such as Test Method Protocols, and Design Verification Protocols, alongside experience writing formal testing protocols and test reports.
  • Experience interacting with medical device regulatory requirements and applicable standards, in particular FDA guidance, ISO 13485 and IEC 60601.
  • Experience working within a Quality Management System to ISO13485 standards.

Don’t have all of these requirements?

Some people are less likely to apply for a role unless they are 100% qualified. Your experience, skills and passion will set you apart - tell us what you have learned and achieved, whether personal or work-related! With the right mindset, many of the skills above can be learned on the job. If this role excites you, don’t let the description hold you back!