Senior Design Assurance Engineer

3 weeks ago

Galway, Galway, Ireland Veryan Medical Full time

Join to apply for the Senior Design Assurance Engineer role at Veryan Medical

Job Overview

Veryan Medical, a fast-paced and rapidly growing medical device company specializing in vascular interventions, is seeking a Senior Design Assurance Engineer to join our team in Galway. This role offers the opportunity to work on innovative projects aimed at improving treatments for peripheral arterial diseases.

Key Responsibilities
  1. Ensure compliance with medical device regulations including MDR 2017/745, MDD 93/42/EEC, FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971, and Japanese Ordinance # 169.
  2. Support development and evolution of design control, risk management, labeling, and packaging systems.
  3. Provide design assurance input to R&D projects and support sustaining activities related to design changes.
  4. Lead risk management and usability engineering activities, maintaining relevant documentation.
  5. Develop and validate test methods, and maintain design verification and validation plans.
  6. Participate in design reviews and support non-clinical studies.
  7. Manage the Design History File and oversee labeling and packaging requirements.
  8. Mentor colleagues and junior team members.
Qualifications
  • Bachelor's degree in Engineering, Science, or related field.
  • Minimum of five years' experience in medical device design assurance, preferably with class III devices or stents.
  • Understanding of ISO 13485, ISO 14971, and FDA QSRs.
  • Experience with risk management, validation, and physical testing.
  • Strong communication and organizational skills.
Benefits
  • Competitive salary and bonus.
  • Pension scheme, private medical insurance, paid sick leave, and group life cover.
  • Generous annual leave and opportunities for professional development.
Company Values
  • Empowering
  • Acting with Integrity

Join us in Galway and be part of a collaborative and innovative team dedicated to advancing interventional medicine.

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