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Job ID: JOB-13627

Design Assurance Engineer – Level I/II 

We have an excellent opportunity for a Design Assurance Engineer I/II to join our team in Structural Heart Valves Design Assurance. We are looking for individuals that share our passion for innovation and advancing solutions for some of the world’s most challenging healthcare issues.   

Purpose:

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system.  Support the application of Design Controls and Regulations in Sustaining Engineering, Post Market and Product Development ensuring that we continue to deliver products of the highest safety and quality to our patients.

Key Activities of the Role:

• Is an active team member completing quality deliverables associated with BSC’s sustaining engineering & post market (commercial product), and new product development support.
• Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment, across multiple global sites, to provide technical and quality systems input.
• Design Control:
• • Understanding of Design Assurance requirements to support marketed product, product development, design changes and technology transfers and to ensure activities comply to all internal and regulatory requirements.
  • Provide detailed assessments of impacts for design and process changes on commercialized products
  • Collaborate in development and execution of Design Verification plans, protocols and reports for new and commercialized products as a member of multi-functional team activities through the life cycle of the product from concept, development, commercialization and end of life phases
  • Assure quality and completeness of documentation associated with design verification studies (including test data, manufacturing records, investigations and deviations) and generate submission packages in conjunction with Project Teams and Regulatory Affairs for regulatory submissions.
• Risk Management:
• • Familiarity with requirements of ISO 14971
  • Manage and update the product’s risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.
• Post Market Surveillance:
• • Familiarity with post market activities such as PSUR, trending, complaints investigation.
• General:
• • Concludes and makes appropriate decisions from test data using excellent analytical and problem-solving abilities
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Provides design quality support in resolving PIRs, CAPAs, non-conforming product, VIPs, and regulatory requirement changes.
  • Support internal and external audits and audit responses for commercialized and new products.
  • Seeks to support improvements in product and process quality.
  • Builds Quality into all aspects of work by maintaining compliance to all quality requirements.

Qualifications and Experience:

• NFQ Level 8 qualification in a STEM discipline
• Minimum of 3-4 years experience in a Design Assurance capacity.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• You have a proven ability to work well both as part of a team and work on your own with minimum supervision.

For further information on this role please contact Katie Kilbane on 086 1283368  / network@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Katie Kilbane

JOB-13627

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