Shape the Face of Cancer Treatment at Luminate Medical

At Luminate, we build products that make cancer care better, faster, and safer for patients. 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. Our long term vision is to enable every cancer patient to get treatment at home.

We’re looking for a Technical Lead (Principal R&D Engineer) to become the next leader in our R&D team. You will be the team leader for our Lily product team. This will include defining user needs, creating product requirements, overseeing design development to meet product requirements, working with subcontractors and suppliers, and overseeing the development of test methods and test method validations. The successful candidate will join our R&D Leadership team, contributing to the company’s overall product strategy, with opportunities to progress quickly into management roles.

The ideal candidate will be familiar with the entire design process from capturing user needs through to testing product requirements and transferring to production. You should have a strong knowledge of data analysis and statistics, testing and validation methodologies, and plastics manufacturing techniques. In addition, you will need an ability to work fast, to bring an intensity that enables rapid progress against project deadlines, and a passion for high quality design.

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:

The Principal R&D Engineer will:

Lead the development of our novel Lily device from clinical stage through to large scale manufacture, including:

• Leading product brainstorming sessions to resolve design challenges and generate new responses to user needs.
• Utilising CAD tools such as CREO and SolidWorks to realise complex product designs and manufacturing fixtures. Reviewing detailed 2D CAD drawing specifications to control design and for manufacture.
• Developing concepts through to manufacture-readiness using techniques such as injection moulding by considering design for manufacture principles.
• Overseeing design transition to production and scale-up.

Lead the design and execution of testing to support product release by:

• Designing testing programmes to support verification of design against product requirements.
• Analysing test data to support compliance with product requirements.
• Reviewing prototype test data and completing statistical analyses to support design decisions.

Oversee the documentation of design inputs to design outputs to ensure compliance with relevant standards through:

• Identifying and documenting user needs in collaboration with Clinical, Marketing and Quality colleagues.
• Translating user needs into product requirements.
• Completing literature reviews and technical reports to support documentation of design inputs, test method designs, and product features.
• Owning risk management documents and leading cross-functional design reviews.

Lead an R&D team through complex medical device design projects to deliver products to patients by:

• Working closely with the Project Management team to identify goals, track progress, and highlight project technical risks.
• Overseeing the work of a team of direct reports and managing inputs from cross-functional collaborators.
• Personally contributing novel and inventive ideas to support patent applications and enhance the company’s IP portfolio.
  

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:

• 7+ years of experience in product development (with at least 5 years’ experience in a medical device environment).

• Previous experience of design for assembly and manufacture of mid to high-volume manufacture of medical devices and/or consumer products.

• Experience of designing at least 3 products using CAD software such as SolidWorks and/or Creo.

• Experience in using Excel/MiniTab/MatLab to input, analyse, and draw conclusions from test data.

• 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.

• Experience working within a Quality Management System to ISO13485 standards.

Experience Advantages – It Would Be Advantageous to Have:

• • Knowledge of validating plastics forming techniques such as dip moulding, blow moulding and thermoforming.
  • Experience interacting with medical device regulatory requirements and applicable standards, in particular FDA guidance and IEC 60601.

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!