Description
Quality Project Engineer/V&V/GMP/medical devices/Dublin/Ireland
Reference: 916170NC
Sector: Pharmaceutical/R&D
Location: Co. Dublin
Start: ASAP
Duration: 6 months +
Job Type: Contract
Introduction:
The V&V Project Engineer is responsible for managing verification and validation activities associated with the development of complex software controlled electromechanical medical devices. Primary responsibilities will include the review of medical device requirements to define and implement system and subsystem level verification and validation testing of medical device products.
Role & Responsibilities:
- Independent innovative thinker with a strong background in bioengineering and/or medical device design
- Experience in development of complex, sophisticated, software controlled electromechanical medical devices and software validation activities
- Experience with electrical, mechanical and software disciplines
- Support Design Reviews with a focus on Requirements definition and V&V activities
- Lead, develop and implement design characterization, DOE's and design verification strategies for efficient, complete and robust testing through report completion and anomaly resolution
- Responsible for developing and performing verification and validation strategies, plans and execution activities to clearly defined acceptance criteria
- Strong understanding of medical device regulations including ISO, FDA GMP and design controls
- Responsible for the methods and tools for automated system testing
- Development of test setups, protocols, results, and reports
- Project Management
- Coordination and Management of Engineering Design Control Documents
- New Product Development ie requirements, verification, and validation
- Sustaining Engineering Support and Manufacturing Transition Project Activities
Skills/Experience:
- Degree in Engineering or equivalent number of years' experience
- Experience in documenting medical device requirements
- Excellent working knowledge of Electromechanical Design, requirements definition and V&V
- 5+ years of applicable industry experience.
- Excellent written and verbal communications skills in English ie minimum B2 level
Nice to have:
- Experience in mechanical ventilation products
- Project management certification is a plus
About Us:
- Since the foundation of our parent company - ITech Consult AG in 1997, we have continually extended our network of computer experts. ITech Consult has offices in Switzerland, Germany, UK and Ireland. Freelance IT specialists benefit from our comprehensive service offerings: including job evaluation, support in the application phase through to legal requirements, setting up of Irish Ltd Companies and on-going administrative support with our clients.