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Materials Science Engineer - 32738

Ref: 260 Date Posted: Tuesday 30 Oct 2018
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Reporting to the Materials Engineering Manager the Materials Engineer will assist in the project & validation engineering of Materials Development projects. 

The job holder will lead the technological improvements and product transfers in conjunction with local Quality, Engineering, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion. They will also be able to successfully move between validation, project and process functions effectively. This role involves providing technical leadership working with a cross functional team to develop and validate advanced manufacturing automated systems for the implementation of leading edge technologies and innovative processes to build excellence in equipment and computer system and process validation. 


Core Project Teams, Operations, Manufacturing Engineering, Line Support Engineering, Quality Assurance Department, New Product Introduction, Materials and Surface Technology, Front End Research and Development 


• Consolidation and validation of Project Plans and deliverables. 
• Manage communication and work commitments with teams’ external to the core team. 
• Facilitate technical problem resolution through the application of best practice tools such as 8-D, DMAIC, etc. 
• Define process outputs, transfer functions, process inputs. Understand sources of variation and inference spaces. Implement process characterization and input control to attain true process validation 
• Understand Validation, Process and Project engineering related to job function/projects and lead the Engineering Team through these areas effectively. 
• Characterize product and process, including identification of CQA’s and CPP’s, performing DOE’s to define relationship models, documenting design space, creation of control plan. 
• Define Material Characterization using advanced analytical techniques 
• Facilitate process FMEA and ensure action follow-up and revisions as required. Utilize other QA risk analysis techniques as required to minimize potential risk during development/implementation activity. 
• Ensure that all changes and activities conform to local and corporate, statutory, legislative and regulatory requirements for GMP, HSE and Quality. 
• Ensure project changes are tracked and actioned appropriately. Implement Engineering Change Control throughout Design / Commissioning and Site Change Control during validation / production. 
• Drive Validation /Verification strategies, authoring Master Validation Plans 
• Ensure correct use of statistical QA methods for the project 
• Create and maintain an environment of innovative continuous improvement, focusing on quality, cost reduction, process development and supply. 
• Co-ordination of effective resourcing of projects and the management of individual performances to defined objectives. 


• 5 years min experience in a Technical Environment – Experience in the areas of polymers, coatings, biomaterials. Experience in Material Characterization (chemical/physical) and in advanced analytical techniques
• 2 years min experience in leading projects, with strong communication, reporting and presentation skills 
• Previously worked with rigorous project management methodology 
• Good organizational skills and orientation to detail 
• Strong time management focus 
• Familiar and experienced in problem solving methodologies 
• Strong influencing and negotiation skills 
• Drive, energy and enthusiasm for delivering to commitments 
• Demonstrated record of strategic thinking and tactical responsiveness 
• Continuous Improvement Focus 


• Bachelor Degree level qualification in Science/Engineering or Equivalent 
• Masters in Engineering and/or Business Administration 
• Minimum 5 years experience in a Technical role with 2 as project leader or in a lead role
• Materials characterization experience – microscopy, chemical-physical analysis, advanced analytical techniques 
• ideally, knowledge and understanding of medical device / pharmaceutical regulated industry including FDA and GMP requirements 
• Working knowledge of Quality Management Standards 
• Working Knowledge of Equipment and Process Validation 
• Six-Sigma Green Belt certified 

• Proficient in Microsoft Project Management 
• Track record of project delivery 
• Extensive Statistical Engineering Expertise (SPC, DOE etc.) 
• Experience in high volume medical device manufacturing environment 

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