Find senior design assurance engineer Jobs in galway, g

Senior Design Assurance Engineer
Luminate Medical —Galway, County Galway
- Full-time
- Microsoft Excel
- No degree
- Communication skills
Quick apply
Senior Design Quality Engineer
Vita Data Sciences —Galway, County Galway
- Full-time
- In-person
Senior Software Engineer-Typescript
Liberty Information Technology —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- AWS
- Software development
- Employee discount
Senior Product Designer
Liberty Information Technology —Galway, County Galway
- Hybrid work
- Master's degree
- IT
- AI
- Employee discount
Senior Design Engineer (Energy & Utilities) - REF: 2621c
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- English
- Microsoft Office
- Bachelor's degree
- Employee assistance program
Quick apply
Civil Project Design Engineer - REF: 2539a
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- English
- Microsoft Office
- Project management
- Employee assistance program
Quick apply
Project Design Engineer - REF: 2518
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- Engineering
- English
- Microsoft Office
- Annual leave
- Employee assistance program
Quick apply
Senior Product Designer
Liberty IT —Galway, County Galway
- Hybrid work
- Master's degree
- IT
- AI
- Employee discount
Project Manager REF: 2617d
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- Engineering
- English
- Microsoft Office
- Employee assistance program
Quick apply
Senior Software Engineer-Typescript
Liberty IT —Galway, County Galway
- Hybrid work
- Computer Science
- AWS
- Software development
- Employee discount
Senior Systems Engineer
MBRYONICS —Galway, County Galway
- Full-time
- System design
- Scripting
- Agile
Software Engineer - MLOps
Liberty Information Technology —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount
Electrical Design Engineer- Transmission & Distribution
NeoDyne —Galway, County Galway
- Overtime
- AutoCAD
- Customer service
- System design
Quick apply
Engineering Manager - REF: 2536a
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- Engineering
- English
- Microsoft Office
- Employee assistance program
Quick apply
Senior Civil Engineer - REF: 2602a
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- English
- Microsoft Office
- Bachelor's degree
- Employee assistance program
Quick apply
Software Engineer AI/ML
Genesys —Galway, County Galway
- Full-time
- Azure
- Computer Science
- Master's degree
8d
Principal Software Engineer - MLOps
Liberty IT —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount
Principal Software Engineer - MLOps
Liberty Information Technology —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount
Software Engineer - MLOps
Liberty IT —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount

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Senior Design Assurance Engineer

Luminate Medical -
Galway, County Galway

Quick apply

Job details

Full-time

Qualifications

Statistical software
Lotus
Microsoft Excel
Minitab
Communication skills
Mechanical knowledge
ISO 13485

Full job description

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 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!

Quick apply

Refine Your Search

senior design assurance engineer jobs in galway, g

Senior Design Assurance Engineer

Senior Design Quality Engineer

Senior Software Engineer-Typescript

Senior Product Designer

Senior Design Engineer (Energy & Utilities) - REF: 2621c

Civil Project Design Engineer - REF: 2539a

Project Design Engineer - REF: 2518

Senior Product Designer

Project Manager REF: 2617d

Senior Software Engineer-Typescript

Senior Systems Engineer

Software Engineer - MLOps

Electrical Design Engineer- Transmission & Distribution

Engineering Manager - REF: 2536a

Senior Civil Engineer - REF: 2602a

Software Engineer AI/ML

Principal Software Engineer - MLOps

Principal Software Engineer - MLOps

Software Engineer - MLOps

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