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Senior Materials Engineer

  • Job reference: 922073
  • Location: Blackpool, Lancashire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 09/10/2018

OrionGroup are looking for a Senior Materials Engineer on behalf of their multinational medical devices client based in the Lancashire area on an initial 6-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.

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.

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. Partner with key functions to understand test analysis and next specs
  • 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
  • Lead Project team when necessary and required as delegate of Direct
  • Support testing & sampling when necessary and required to ensure successfully project tasks completion
  • Communicate with key stakeholders when required

Desired Skillset and background of the successful candidate:
* 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
* 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

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


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.