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Engineering Team Leader

Job Title: Engineering Team Leader
Contract Type: Permanent
Location: Runcorn, England
Industry:
Salary: $65000 - $70000 per annum
Start Date: 2019-04-25
Reference: BH-107104
Contact Name: Ellen Twomey
Contact Email: ellen.twomey@nesgt.com
Job Published: April 26, 2019 11:38

Job Description

Engineering Team Leader

Runcorn

 

Reporting to the Engineering Manager, the Engineering Team Leader will:

  • Manage a team of Engineers, both internal and external/contract, to design and develop needle-based injection devices within a Design Controls environment.
  • Ensure that the products for which your team is responsible are safe and effective through the application of appropriate engineering design, analysis and Safety Risk Management.
With this role there are challenges to overcome, problems to investigate and solve, innovative solutions to develop and implement.  Through the support that the Engineering teams provide, the Engineering Team Leader will contribute directly to the development of innovative devices and new primary pack technologies.

 

Key responsibilities:

  • Direct line management responsibility for a team of Engineers (approx. 4-6).
    • Ensuring that all members of the team are suitably trained to fulfil their roles and that the team’s skills and capabilities are developed to their full potential.
    • Recruitment, performance management and other HR support.
  • Managing the provision of Engineering resources to meet the needs of SDT’s device development projects.
    • Resource planning and project assignment of the Engineers within your team, responding to the changing business priorities and project needs.
    • Engaging and managing services from external contract design houses, contract manufacturing companies and specialist external suppliers.
    • Understanding and managing stakeholder’s expectations, both internal (e.g. SDT Project Managers) and external
  • Directly supporting projects in the role of “Design Authority”, leading the engineering design and development of drug delivery devices at various stages of development, from research, through verification and validation, and into life-cycle management.
  • Ensure that products for which you are responsible are:
    • Engineered to be reliable and robust, through the application of appropriate design, analysis and testing.
    • Verified by the provision of suitable objective evidence.
    • Documented in compliance with Quality Management System.
  • Lead the Safety Risk Management activities
    • Including Hazards identification, analyzing and evaluating risk, conducting design and process FMEA.
  • Lead or support technical design reviews to assess robustness and safety and documentation quality compliance.
  • Lead investigations to identify root causes of device issues, e.g. Fault Tree Analysis, Design of Experiments.
  • Play a leading role in the continuous improvement of departmental processes, including supporting development of Standard Operating Procedures, guidelines and templates, introduction of new software tools etc.
  • Some domestic and overseas travel may be required approximately 5-10%.
Qualifications

  • Graduate in Engineering, Scientific or other Technical discipline, or equivalent.
  • Significant experience in the design, manufacture and life-cycle management of medical device or combination products from concept to commercialisation (preferred, or, as a minimum, significant expertise from another relevant industry).
  • Line management experience of an engineering team (preferred).
  • Training in Design Controls, medical device risk management and European Medical Device Directive/Regulations (preferred).
  • Familiarity with statistical methods, for example for the determination of design input requirements, verification and validation testing.
  • Knowledge of Solidworks 3D CAD (preferred).
  • Advanced skills in mentoring and coaching skills.
  • Ability to objectively assess projects, identify gaps or challenges and direct problem solving activities.
  • Strong problem solving capability. 
  • Exhibits ingenuity, creativity and resourcefulness.
  • Analytical engineering assessment of mechanisms and systems.
  • Good verbal and written communication including high quality engineering documentation.