Design Assurance Engineer job
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Design Assurance Engineer
Our Client is a leading global provider of medical devices for the hospitals, emergency, home and specialist environments whose products are used during critical care, surgery and post operative care during recovery. They employ over 7.5000 people and their aim is to build a rewarding relationship with each their customers and they are continually working on ways of improving their products and services.
They now seek an experienced Design Assurance Engineer who will be responsible for performing design assurance engineering work in all conventional aspects of mechanical or electrical engineering. A candidate will be based in Hythe.
Assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes). Conduct Design Assurance engineering activities and perform generally assignments with limited supervision/instruction as to expected results. Review new product development and improvement project plans Review Change Control documentation Review product risk analyses Review engineering requirement specifications Review product design documents Review product test plans and results Review product change requests Review Design Verification and Validation protocols and report Review product and process validation test plans Participate in critical component/process review Participate in Technical Design Reviews Participate in Standards Reviews Review Control Plans Review Risk Management Plans (ie Application FMEA, Design, Process FMEA) Support market surveillance for new product releases Review Quality plans Participates in and conducts training and development programs designed to increase knowledge in issues related to medical device manufacturing and development, such as GMP, Total Quality, Product Compliance/Certification etc. Oversees preparation of documentation associated with design assurance engineering activities to include drawings/schematics, verification/validation/capability testing, various new and revised operating procedures, risk analyses, etc. Monitor new projects and interacts with other engineers to determine design criteria. Generate/review test specifications and test methods. Generate/review documentation associated with verification/validation of equipment, products, and components Maintain communications within and outside of department in support of design assurance engineering activities, such as project management meetings, design reviews, etc. Actively participate in and contributes to the decision-making process Interfaces with development, design, and manufacturing engineering areas to resolve quality and product issues. Interface with Suppliers on New Product Development and Design changes and actively works with suppliers for component procurement and acceptance. Generate periodic activity and project updates reports
Candidates will have:
Technical Knowledge and Skills:
Ideally Bachelor's degree in Mechanical/Electrical Engineering or related engineering field, with professional level experience within the medical, or a closely related industry. Specific experience in design assurance desirable. Or Masters degree in engineering, with medical or closely related experience Knowledge of mechanical engineering, as well as competency in related specialty fields (electrical engineering, etc.). Uses considerable judgment in the planning, scheduling and coordinating of project phases, as well as the selection of engineering techniques and criteria. Demonstrated effective analytical and problem solving skills to identify root causes and probable solutions quickly. Applies to design and manufacturing environments, as well as meeting departmental goals. Able to effectively utilize other resources when necessary to resolve issues, especially those outside expertise. Experience working with sterile products, related components, processes and clean room environment. Experience working with electromechanical products, related components and processes. Able to plan and conduct effective meetings and group presentations. Knowledge and skill in mechanical engineering documentation procedures, development methods and project management, with the ability to rapidly master company's internal procedure and methods, such as Documentation System, ECOs, DOEs, DVTs, MDAs, etc. Depth of knowledge of applicable QSSOPs, regulations, and standards etc. with proven skill in integrating into mechanical engineering discipline. In depth knowledge of ISO 13485, ISO 14971, 21 CFR 820 Design Controls. Knowledge of Statistical Process Control (SPC) and quality tools including sampling, tables, andCPK; ability to design and perform required tests using appropriate tools. Knowledge of drafting including CAD design; ability to utilize electronic drafting aids (such as CAD programs) for mechanical design. Familiarity with interpreting electronic design documents, primarily schematics and PCB layout. Proven experience with documentation systems, testing and inspection procedures, validation and qualification expertise.
Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout UK, Ireland, Europe and Australia.
For more information go to our website.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Nina Kodric or send applications.
We are acting as an Employment Agency.