Job Description
Within our Structural Heart Design Assurance Department, we focus on partnering with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products, methodologies, processes and departmental interfaces. to ensure the performance and safety of the Structural Heart devices we develop, is assured and maintained throughout the product lifecycle.
Responsibilities
- At the appropriate point during post commercialization, work to ensure a smooth transition of product Quality responsibilities from DAE to the Post Market Product Assurance group (reliability/performance metrics reporting, etc.).
- Prioritize timely completion of complaint investigations, CAPA decisions, and DHR reviews, ensuring that corrective action decisions and investigations are based on sound engineering analysis and review.
- Develop and maintain a robust process for identifying and monitoring root cause failure mode`s, frequency, and severity. Provide statistical data to QA and management on product performance, effectively describing clinical observations and the relationship with device performance.
- Represent QA in product Risk Analysis updates for assigned products.
- Collaborate with returned product analysis lab to derive root cause and lead failure investigation activities for returned products.
- Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements.
KEY SKILLS & EXPERIENCE
- We are looking for a qualified person to Minimum of a bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 2 years relevant experience.
- Established and productive individual contributor.
- You are a dynamic team player, can work effectively and proactively on cross-functional teams.
- Sets objectives for own job area to meet the objectives of projects and assignments.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- You are experienced to a competent level within Medical Device Design.
- Excellent communication and ability to influence is critical to the role. You must be fluent in English, both in writing and speaking.
