Quality Engineer II

Shape the Future 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 Quality Engineer II to support our expanding Quality function. 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 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:

Work as part of the Quality team in the overall support of design and manufacturing activities, through the introduction of new technology/techniques, skill development, training, process optimisation and cost saving projects.

Provide specialist quality and technical engineering support to all departments.

Support the maintenance, management and improvement of our Quality Management System in accordance with ISO 13485 and other applicable regulations.

Monitor companywide training programme and compliance.

Provide guidance, coaching and training to other employees within job area.

Set high standards and drive accountability in the execution of responsibilities and model ethical behaviour.

Participate in cross-functional teams and continuous improvement process efforts through corrective and prevention actions to solve problems or drive efficiencies.

Set objectives for own job area to meet the objectives of projects and assignments.

Contribute to the completion of project milestones.

Support regulatory activities to ensure successful completion of market approval submissions to FDA and other regulatory bodies.

Report progress against agreed timelines at meetings with management.

Continually look for opportunities to optimise processes.

Participate in internal/external audits as required.

Participate in job-related training courses.

Personal Attributes – The Ideal Candidate Is:

Detail-oriented : Able to identify even minor deviations from specifications.

Ethical and professional: Consistently acts with integrity, particularly when reporting or escalating quality issues.

Accountable : Takes ownership of inspection accuracy, documentation, and results.

Patient and thorough : Works methodically and adheres strictly to established standards without cutting corners.

Adaptable : Responsive to changing priorities, inspection schedules, and product lines.

Proactive : Raises concerns early, suggests improvements, and actively participates in problem-solving efforts.

A collaborative team player : Works effectively with operators, engineers, and quality colleagues.

Resilient and focused : Maintains accuracy and concentration under time pressure and during repetitive tasks.

A clear communicator : Able to explain inspection findings precisely, both verbally and in writing.

Committed to compliance : Consistently follows cleanroom protocols, SOPs, and regulatory requirements.

Experience Requirements – The Ideal Candidate Must Have:

Level 8 degree or equivalent in relevant discipline (e.g. Engineering/Science /STEM/ASQ CQE).

Minimum of 2 years relevant engineering experience within an ISO certified medical device company.

Strong understanding of ISO 13485 standard, FDA Part 21 CFR 820 and other medical device regulation.

Excellent problem-solving and root cause investigation skills.

Proficient in using quality management systems (QMS) and MS Office Suite.

Good documentation skills and attention to detail.

Strong communication and organisational skills.

Proactive approach to problem-solving.

Ability to work independently with minimal supervision and cross functionally.

Confident communicating with internal and external stakeholders.

Experience Advantages – It Would Be Advantageous to Have:

Lead Auditor Certification.

Previous experience working in a start-up company.

Familiarity with statistical analysis and quality tools (e.g. SPC, FMEA, 5-Whys, Fishbone).

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!