Description
Senior Materials Engineer - Science - Six Sigma - FMEA - SPC - DOE
The job holder will lead the technological improvements and product transfers in conjunction with local Quality, Engineering, Operations and DePuy 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.
MAIN DUTIES & RESPONSIBILITIES:
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.
Experience in a Technical Environment - Experience in the areas of polymers, coatings, biomaterials. Experience in Material Characterization (chemical/physical) and in advanced analytical techniques
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 & EXPERIENCE
ESSENTIAL:
Bachelor Degree level qualification in Science/Engineering or Equivalent
Masters in Engineering and/or Business Administration
Experience in a Technical role
Proven Project Management 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
DESIRABLE:
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
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.