DESIGN SERVICES (N W) LTD

Design Verification Engineer (Validation)
Contract Opportunity
Location East Cheshire
Duration Min six months
RATE; Circa £55 per hour depending on Experience and Qualifications
Industry Medical Equipment

Reporting to the Senior Team, your duties will include the following:
• Making recommendations about required work and ways to meet compliance regulations
• Producing technical validation and verification reports

Key responsibilities will include but not be limited to the following:
• Assist with the remediation projects from beginning to completion
• Managing, developing, and driving proposals forward and planning for the remediation project covering all associated regulations and standards
• Implementing the remediation proposals and handling all technical aspects
• Performing generic and detailed quantitative risk assessment
• Builds verification strategies and testing protocols for proposed changes in existing design specifications: materials, electronics, software or integrated system
• Actively participates in risk management meetings related to proposed change: hazard/harm analysis, and FMEAs within a cross-functional team
• Involvement in DFEA’s and PFMEA’s on NPI introduction
• Provides expertise in risk management and analysis techniques
• Use latest testing methodologies and standards
• Strong knowledge in regulated process and procedures
• Ensures tools, methodologies and testing standards are appropriately applied to achieve project aims, Informs in a timely manner on remediation activities status
• Ensures the DHF are complete and up to the current external and internal standards
• Capable of working to tight schedule and cost targets

Qualifications/Skills:

• A degree in engineering or science discipline preferred
• Experienced in definition of functional system requirements, requirements traceability and flow down.
• Familiar with test and integration methods for hardware and software product designs
• Experience on formal testing of complex systems
• Understanding and experience with Design Controls 21 CFR 820 and ISO 13485:2016, Risk Management ISO14971:2012 associated with the medical device industry.
• Proven experience with DFMEA, FTA and reliability analysis.
• Experience and adherence to a formal Change Control quality system
• Strong technical and analytical skills to prove and support implementation of proposed design changes
• Problem solving skills to complex applications.
• Critically evaluate proposed study designs with strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power.
• Electrical, EMC, RED Safety and Environmental Standards compliance experience
• Knowledge of test automation such as LabVIEW, SQL, MATLAB etc
• Strong interest in technology innovation
• Awareness of Six Sigma and Lean tools such as Ishikawa, 5 Whys, Capability studies etc
• Experience of CAPA systems
• Ability to follow through on tasks to completion
• Work independently and within the team
• High degree of initiative and self-motivation
• Professional written and verbal communication skills
• Good interpersonal and organisational skills
• Excellent written and oral communication skills
• Fluent in English.

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