Senior Design Assurance Engineer — Medical Devices

Luminate Medical; Galway; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Health Insurance

Pension

Laptop

Headphones

Camera

Flexible hours

Generous vacation

Job summary

Luminate Medical is seeking a Senior Design Assurance Engineer to help ensure quality, compliance and scalability as we move from development to commercial stage. You will influence design decisions, lead risk management and verification activities, and collaborate with external partners to bring life-changing medical devices to patients.

You will work in a fast-paced startup environment, enjoying responsibility, and contributing to a flexible benefits package including health insurance and

Qualifications

• Level 8 degree or equivalent in Engineering/Science.
• Minimum 3 years of relevant engineering experience.
• Experience in ISO 13485 QMS or equivalent.
• Strong experience with design controls, reviews and change processes.
• Strong experience with FMEA (design and/or process).
• Knowledge of FDA and ISO compliance.
• Proficient in MS Excel or Minitab for data analysis.
• Able to write engineering docs, test protocols and validation reports.
• Excellent communication, organizational and project planning skills.
• Ability to lead or work in a team.

Responsibilities

• Support Design Verification and Design Validation testing and associated 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.
• Support development of test methods and work instructions.
• Support Human Factors and Usability studies.
• Influence design of new products and processes based on business strategy.
• Provide guidance, coaching and training to other employees.
• Ensure smooth transition of activities from design to manufacturing (DFMEA to PFMEA).
• Work with external design/manufacturing partners and suppliers.

Skills

Design Controls

Design Reviews

FMEA

Root Cause Analysis

Problem Solving

Data Analysis (Excel/Minitab)

Technical Writing

Teamwork/Leadership

Communication

Education

Bachelor's degree or higher in Engineering/Science

Tools

MS Excel

Minitab

Job description

Luminate Medical is seeking a Senior Design Assurance Engineer to help ensure quality, compliance and scalability as we move from development to commercial stage. You will influence design decisions, lead risk management and verification activities, and collaborate with external partners to bring life-changing medical devices to patients.

You will work in a fast-paced startup environment, enjoying responsibility, and contributing to a flexible benefits package including health insurance and