Senior Design Assurance Engineer — Medical Devices

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

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