Sector: Life Sciences
Consultant: Danny Smith
Salary: £65000 - £80000
Job Status: Permanent / Full Time
My Client in Dublin is looking to recruit Senior Software Quality Engineers. You will work closely with the new product development teams consisting of software, system and test in the development of new software releases for software as a medical device.
- Requirements definition
- Software architecture and design
- System level risk management reviews and Failure Mode and Effects Analysis
- Verification and validation testing and reporting oversight
- Automated testing oversight
- Software defect disposition
- Product performance reviews
- DHF audits
- Non-product software requirements definition and verification testing.
- Execute work using an Agile Scrum framework to manage development activities.
- Engage in a collaborative, diversified and energetic team environment focused on delivering high quality products to our patients and users.
A Day in the Life
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Reviews include applicable specifications, materials, tools, techniques, and methodologies.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
Must Have: Minimum Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
Nice to Have: (Preferred Qualifications)
- Experience with software as a Medical Device or software as an accessory to a Medical Device
- Performance of risk analysis activities for a given clinical product
- Development of or previous oversight of manual or automated testing used in verification activities
- Experience working in an Agile Scrum Framework
- Strong understanding of the application of 21 CFR Part 11, 820 and FDA Guidances pertaining to the development and use of software as a medical device
- Strong understanding of the application of the ISO standards, 13485, 14971, 62304, 62366 and 60601