Materials Engineer

PE Global International
11 Feb 2018
16 Feb 2018
Contract Type
Full Time
PEGlobal are looking for a Materials Engineer for our multinational medical devices client based in the Lancashire area on an initial 12 month contract.
Job Purpose:
Reporting to the Materials Engineering Manager the Senior Materials Engineer will provide a lead role in the project & validation engineering of Materials Development projects.
Main Responsibilities of the role:
• 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 Project Management
• Track record in team leadership including strong mentoring & coaching skills demonstrated in a business environment
• 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

Qualifications and Skillset Associated with the successful candidate:
• Bachelor Degree level qualification in Science/Engineering or Equivalent
• Masters in Engineering and/or Business Administration
• Minimum 5 years’ experience in a Technical role
• Proven Project Management experience (min 2 years’ experience)

• Materials characterization experience – microscopy, chemical-physical analysis, advanced analytical techniques

• Proven 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

• Certification in Project Management and experience in the Health Care Industry
• 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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