Senior Validation Engineer

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Senior Validation Engineer

Our client is a Global leader in the Design, Development and Manufacture of complex disposable dressings and electro-mechanical wound healing devices for challenging environments. They are looking for a Human Factors Engineer to join the team on a permanent basis to take lead responsibility for a small team and be the technical point of call for clients and peers.

Job Description

Senior Validation Engineer - Medical Devices Dorset Up to £41k + benefits

Role:
Working independently as the Usability Engineering Process Subject Matter Expert (SME) within local and global New Product Development project teams focusing on the practical and pragmatic implementation of the usability engineering / human factors process to generate commercially successful and usable medical products. The products include novel wound dressings and wound healing devices which are used in varied, often challenging use environments. The role also provides validation oversight to a small R&D facility. As a senior position the role involves providing subject matter guidance to junior team members and demonstrating experience-based professional judgement.

Major Responsibilities
" Act as a Usability Engineering Process SME within global cross-functional NPD project teams
" Offer guidance to technical teams to ensure the design of products meet usability standards and regulatory expectations
" Apply the Usability Engineering Process to multiple concurrent New Product Development projects including:
o Document the intended user, intended uses, and intended use environment
o Perform task analysis
o Perform risk analysis in accordance with IEC 62366-1 / ISO 14971
o Review user needs and engineering requirements
o Manage internal and external resources to support formative and summative user interface evaluations
o Ensure the usability engineering file complies to design control requirements and compliance standards
" Review usability risk analysis (FMECAs) for sustaining engineering projects
" Manage the calibration process for on-sight equipment
" Perform equipment qualification (installation IQ/OQ) for new lab equipment
" Perform data integrity review and statistical analysis of competitive testing
" Facilitate team meetings to discuss usability issues observed during usability testing and communicate potential design solutions
" Facilitate trade-off analysis between the occasionally conflicting requirements of usability and business needs
" Support the development of the Usability Engineering and Testing group within the R&D organisation

The candidate will have:
" At least 5 years experience in an industry setting preferably in a product development environment.
" Knowledge and experience of the tools and techniques required to apply Usability Engineering to products in development is highly desirable.
" Previous experience working in small multi-disciplinary design teams is highly desirable
" Knowledge of FDA and MDD requirements for the application of Human Factors to medical device design is highly desirable
" Intermediate level understanding of Microsoft Excel
" Intermediate level understanding of MS Word

Education:
" Minimum degree level in an Engineering related discipline.

Personal Characteristics:
" Able to demonstrate a complete understanding and wide application of technical principle, theories, and concepts in the field. General knowledge of other related disciplines.
" Able to provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practical, and consistent with organization objectives. Anticipates problems and recognizes when to deviate from standard practices.
" Able to work under only general direction demonstrating excellent time management and multi-tasking abilities. Independently determines and develops approach to solutions.
" Able to contribute to the completion of specific projects milestones.
" Able to demonstrate a methodical and pragmatic approach.
" Excellent written and verbal presentation
" Able to demonstrate excellent communication and collaboration skills with primarily internal company contacts and frequently with inter-organizational and outside customer contacts. Represent the organization in providing solutions to difficult technical issues associated with specific projects.
" Able to work with team members who are located globally
" Willing to travel occasionally to development teams in the United States and across Europe, for direct contact and interaction with these teams and overseeing usability testing

Advanced Resource Managers Engineering Limited operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.

Key Consultant

Gemma Langley

Gemma Langley profile

I head the Manufacturing &Technologies division and we focus on products that have been designed and manufactured across a breadth of engineering industries. The division covers a range of markets including CEM’s, electronics, automotive, aerospace, rail, avionics, defence, manufacturing, medical, pharmaceutical, semiconductor and machinery & automation.