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 manufacture products which revolutionise the patient experience of cancer treatment by eliminating the side effects of cancer treatment in a comfortable, portable and effective way.

We are approaching key milestones in product development and commercialisation. As we scale, we are seeking a dynamic and hands-on Principle\Senior Design Assurance Engineer (level of seniority depending on experience, and this will be a Hybrid role) to support our expanding manufacturing, facilities, and supply chain functions. This role is pivotal in ensuring quality, compliance, efficiency, and scalability as the company transitions from development to commercial stage.

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 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 (or exceeding) multinational medical device companies, a flexible benefits package, alongside a company laptop, headphones and camera.
Training and personal development is a key part of our culture. Comprehensive training will be provided. In addition, we will provide opportunities to develop and grow as an individual.
We believe in quality of life in our products and for our people, and offer flexible working hours, along with a progressive personal time 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.
Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results.
Provide guidance, coaching and training to other employees.
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: 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: Strong 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. You engage in ongoing personal development.
Organised: You can prioritise your list of tasks independently and ensure actions are completed on time.
Teamwork: You enjoy working in a multidisciplinary team, all working towards a common goal.

Experience Requirements – The Ideal Candidate Must Have:

Qualification: Engineering , scientific or technical degree (ASQ CQE accepted)
Experience: 6 years+ relevant engineering experience in Design Assurance.
- 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!

Senior/Principal Design Assurance Engineer

Benefits

Job Description