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!

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 support our expanding product portfolio. This role is pivotal in ensuring quality, compliance, efficiency, and scalability as the company transitions from development to commercial stage. 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.

• 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.

• 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:

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

• Minimum of 3 years relevant engineering experience.

• Experience within an ISO 13485 QMS or equivalent environment.

• Strong experience of design controls, design reviews and design change processes.

• Strong experience in use of FMEA and/or design FMEA and/or process FMEA.

• Strong experience in problem solving & root cause investigations.

• Knowledge of FDA and ISO compliance.

• Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry.

• Ability to analyse and chart data using MS Excel or Minitab or other statistical software.

• Ability to write engineering documents, test protocols, FMEAs, validation protocols, technical reports.

• Strong personal initiative and strong interpersonal skills.

• Ability to work well as part of/and lead a team.

• Strong communication, organizational and project planning skills.

Experience Advantages – It Would Be Advantageous to Have:

• An understanding of IEC 60601 and IEC 62304 requirements as they relate to medical device design and testing.

• An understanding of ISO 10993 requirements as they relate to medical device design and testing.

• Prior experience dealing with regulatory agencies or notified bodies in Medical Devices and or Pharmaceuticals is desirable.

• Previous experience working in a startup or SME environment.

• Validating test methods and test equipment or test software.

• Strong background in the use of statistical methods.

• 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!

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