Ref No: AM17302
Co. Dublin, Ireland
Verification Engineer - South Dublin.
We are seeking an experienced Verification and Validation Engineer to lead activity focussed on product performance testing and analysis (including formal verification and validation) of a complex electro-mechanical drug delivery platform currently in Research and Development.
We are recruiting for a highly-driven technical lead with a passion for problem solving and a proven track record of successfully developing medical products.
The successful candidate will have a unique opportunity to build and lead a high-caliber R&D team responsible for test method development, verification and validation in a growing business.
The successful candidate will be responsible for leading product verification activities and will lead test method development activities, measurement system development & analyses, test fixture design, and equipment hardware/software validation of measurement system equipment. He/she will work with the R&D and cross-functional team to ensure that translated product requirements are testable and measurable.
You will also participate in executing technical and cross-functional project work which includes all phases of product development, including design and development planning, requirements definition, product development, root cause analysis, test method development, design verification/validation and reliability.
Key Responsibilities will include:
Define, plan and lead activities, including, test method & measurement system development and validation, fixture design and testing optimisation in support of Design Verification.
Participate in the planning and execution of technical project work. This will involve the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues and root causes, and to propose and implement robust solutions.
Collaborate with cross-discipline Design & Development, Systems Engineering and other Engineering teams to ensure that product requirements are testable and measurable.
Critically evaluate and analyse system performance and reliability and ensure the design space is adequately pressure-tested to satisfy user, regulatory and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
Implement DFSS rigour throughout the design selection and development process, leveraging and deploying empirical, statistical and analytical tools which will improve design decisions and reduce design iteration cycle times.
Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, usability, reliability and safety.
Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
Synthesise, develop, update and optimise designs that meet requirements by understanding design space with design options and tradeoffs, managing critical parameters, leverage strong engineering fundamentals and tools, and integrating manufacturing principles early in the development.
Actively build on personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
Working effectively as part of a dynamic team to collaboratively reach project targets and milestones.
Manage and execute activity with external test vendors.
Ensure compliance with quality policies, procedures, and practices.
Adherence to good laboratory practices (GLP) for product testing and good documentation practices (GDP) through planning, performing, monitoring, recording and reporting on product testing.
Interested applicants should have:
Bachelor’s degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering or similar.
At least 6 years' professional experience leading or supporting product development projects
Medical Device design controls knowledge and expertise
Proficiency in statistical methods / tools
Experience with implementing product changes through a structured, phase-gated product development process
Experience solving problems, providing detailed insight and constructive criticism in complex situations, and foreseeing problems along with potential solutions
Leadership and team-building skills
Experience with design best practices, including design for reliability.
Working with regulatory standards
Strong project management skills