Senior Design Assurance Engineer Role
Our client, a medical science leader for over 40 years, is dedicated to addressing the most pressing challenges while prioritizing human life. Their mission is to advance science for life, transforming lives through innovative medical solutions that enhance patient outcomes, create value for customers, and support employees and communities.
We have an exciting opportunity for a Senior Design Quality Assurance professional to join our expanding team. As part of the Design Quality Assurance team, key responsibilities include demonstrating commitment to the Quality Policy by executing sound quality practices and maintaining an effective quality system.
The Design Quality Assurance team supports a diverse product portfolio including drug-coated stents and balloons, balloon dilatation catheters, and cutting balloons for Interventional Cardiology. The successful candidate will lead projects related to the drug-coated balloon product line and provide supervision within their reporting structure, offering coaching and mentoring support including assignment and oversight of small to medium projects.
The role requires leading projects to ensure quality, compliance, material continuity, and design Value Improvement Projects (VIPs), ensuring all design changes comply with associated regulations and procedures.
Key Responsibilities:
1. Demonstrate in-depth understanding of medical device Design Control requirements and procedures.
2. Ensure project deliverables meet internal and regulatory Design Assurance requirements.
3. Provide design quality leadership in resolving issues related to PIRs, CAPAs, NCEPs, and regulatory requirement changes.
4. Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
5. Analyze test data using analytical and problem-solving skills to make informed decisions.
6. Lead design change projects including scoping, assessment, and implementation, contributing individually and directing team members.
7. Update documents within the Risk Management File, such as Hazard Analysis, Task and Use Error Analysis, and Design FMEA.
8. Maintain regulatory compliance with company SOP/WI's and global guidelines.
9. Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
10. Support internal and external regulatory audits as needed.
11. Provide direction and support for post-market surveillance activities, including Field Signal Evaluations, assessment of field product performance, NCEPs, PSURs, and Q&A from regulatory authorities.
12. Offer coaching and development support within their reporting structure, including assignment and oversight of small to medium projects.
Education & Experience:
13. NFQ Level 8 qualification in a STEM discipline.
14. A minimum of 6 years' industry experience, with Design Assurance experience being desirable.
15. Experience in areas like design control, risk management, design change, and standards compliance to regulatory requirements.
16. Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills.
17. Proven ability to work effectively both individually and as part of a team.
18. A strong enthusiasm for developing their career, demonstrating best practices aligned with department and site objectives, and driving improvements in product and process quality.
19. A willingness to coach and develop team members.