Senior Design Assurance Engineer

Luminate; Galway; Hybrid; EUR 75,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Pension

Company laptop

Job summary

Luminate Medical is seeking a Senior Design Assurance Engineer to support multiple high-impact medical devices. You will drive verification/validation, design controls and design reviews, and regulatory documentation, while partnering with cross-functional teams to ensure quality and compliance.

The role offers a fast-paced startup environment with a strong patientImpact focus. The ideal candidate has a Level 8 degree, 3+ years of experience in medical devices, and fluency in design quality

Qualifications

• Level 8 degree or equivalent in 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 FMEA and/or design FMEA and/or process FMEA.
• Strong experience in problem solving and root cause investigations.
• Knowledge of FDA and ISO compliance.
• Excellent working knowledge of Quality System Requirements within Medical Device/Healthcare.
• Ability to analyse data with MS Excel or Minitab or other stats software.
• Ability to write engineering documents, test protocols, FMEAs, validation protocols, reports.
• Strong initiative and interpersonal skills; team player.

Responsibilities

• Support Design Verification and Design Validation testing and methods.
• Lead or support corrective and preventive actions to improve designs and test methods.
• Lead or support Design Controls and Design Reviews processes.
• Support compiling technical documentation for regulatory submissions.
• Develop test methods and work instructions as required.
• Support Human Factors and Usability studies.
• Influence design of products, processes, standards with business strategy.
• Provide guidance, coaching and training to others.
• Ensure smooth design-to-manufacturing transitions (DFMEA to PFMEA etc).
• Collaborate with external design/manufacturing partners and suppliers.

Skills

FMEA

Root cause analysis

Statistical analysis

MS Excel

Minitab

Regulatory knowledge

Quality systems

Team leadership

Communication

Education

Bachelor or equivalent in Engineering/Science/STEM

Tools

Minitab

Job description

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 devicesdesigned toaddresshair loss andperipheral neuropathy respectively – two of the most common anddifficult 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!