Shape the Face of Cancer Treatment at Luminate Medical
At Luminate, our mission is to make cancer care more human. We design and 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 have an exciting pipeline focused on building products that help cancer patients to live, not just survive. Our latest product Lotus enables at-home administration of low-risk anti-cancer drugs.
We’re looking for a Senior Design Assurance Engineer to provide quality expertise across our portfolio of products. This is an exciting opportunity to be part of a multi-award-winning team and play a decisive part in the development and production of life changing devices. Above all, you will need to enjoy working in a fast-paced environment, be passionate about working with people, and thrive in taking responsibility for delivering projects on-time to make a real-world 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 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, 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, and offer flexible working hours, and a generous vacation policy.
What You Will Do:
- Support Design Verification and Design Validation testing and associated methods.
- Lead or support corrective and preventive actions to continuously improve our designs and test methods.
- Lead or support Design Controls process and Design Reviews process.
- Support compiling technical documentation in relation to regulatory submissions.
- Support the development of test methods and associated work instructions as required
- Support Human Factors and Usability studies.
- Ensure smooth transition of activities from design to manufacturing e.g. transition of dFMEA to pFMEA, transition of Design Specifications to Manufacturing Specifications, transition of Design Test Methods to Process Test Methods, etc.
- Work with existing and future external design\manufacturing partners and suppliers.
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: Proficient in written and verbal communication and collaboration skills. You are able to share ideas and support exploration of other ideas.
- Self-Driven: You have a sense of urgency in your work and thrive when taking responsibility for tasks.
- Organised: You can prioritise your list of tasks with input from more senior colleagues and ensure actions are completed on time.
Experience Requirements – The Ideal Candidate Must Have:
- Qualification:
- Engineering, scientific or technical degree (ASQ CQE accepted)
- Experience:
- 3 years+ engineering experience in Design Assurance or R&D.
- Within an ISO 13485 QMS or equivalent environment.
- Strong experience of design controls and design reviews and design change processes.
- Strong experience in use FMEA and\or design FMEA.
- Strong experience in problem solving & root cause investigations
- Technical Skills:
- Use of statistical tools.
- Proficient in MS Excel & MS Word.
- Communication Skills:
- Comfortable and confident communicating with internal and external stakeholders.
Experience Advantages – It Would Be ‘Nice to Have’ \ Advantageous to Have:
Experience:
- Process or test equipment validation experience.
- Previous experience working in a startup or SME environment.
- Optimising processes with a view to Design for Manufacturability (DFM).
- Validating test methods and test equipment or test software.
- Strong background in the use of statistical methods.
- Experience working with sterile devices.
- Experience working with electro-mechanical equipment or devices containing software.
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!
