We are seeking a skilled professional to join our medical device company as a Design Assurance Engineer. This role offers an exciting opportunity to collaborate with an innovative and dynamic team focused on delivering high-quality, life-changing products.
Job Description:
This is a critical position that requires the successful candidate to play a key role in ensuring product compliance, driving design changes, and supporting post-market activities. The ideal candidate will have a strong understanding of regulatory requirements and industry standards, including FDA 21 CFR 820.30, ISO 13485, and ISO 14971.
Responsibilities:
* Ensure product compliance throughout the product lifecycle.
* Lead and implement design/material changes aligned with regulatory and internal standards.
* Provide input on process changes with R&D and Manufacturing teams.
* Apply risk management per ISO 14971 and ISO 13485.
* Maintain risk files for post-market products.
* Plan and execute design verification and shelf-life testing.
* Ensure design control compliance, including DHF maintenance.
* Support complaint investigations, root cause analysis, and CAPA activities.
* Stay current on regulatory changes and best practices.
* Contribute to documentation including specs, drawings, and procedures.
* Assist in audits and regulatory submissions.
* Work cross-functionally on product updates and improvements.
* Mentor junior engineers and drive continuous improvement.
Qualifications:
* Bachelor's degree (Level 8 NFQ) in Engineering, Science, or related discipline.
* 2–3 years' experience in design assurance, quality, or product development (medical device industry).
* Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.
* Experience in:Design controls and verificationBiocompatibility and sterilisationUsability and human factorsRisk management and statistical analysis
* Familiarity with post-market surveillance and CAPA.
* Strong communication, analytical, and documentation skills.
* Detail-oriented, proactive, and effective in fast-paced, team-based environments.
What We Offer:
A dynamic work environment, opportunities for growth and development, and the chance to contribute to the creation of life-changing products.