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Chief Engineer Design Integrity

Job Title: Chief Engineer Design Integrity
Contract Type: Permanent
Location: Bristol, United Kingdom
Industry:
REF: 2080
Contact Name: Andra Serban
Job Published: 11 days ago

Job Description

 

  • Act as the independent authority for the S3(UK) to certify product designs on behalf of the Company for the Line of Business (LoB).
  • Act as "responsible person" for EU Declarations of Conformity.
  • Work closely with S3(UK) to ensure that the products and projects are developed in accordance with mandated requirements of the Engineering Lifecycle, are compliant with contractual and legal requirements, are tolerably safe, and are fit for purpose.
  • Assure that any statement with respect to product compliance made on behalf of the Company, is independently verified.
  • Support the S3 (UK) LoB and Integrated Project Teams ( IPTs) by providing advice in planning product compliance, acting as Design Review chairman or assessor, and facilitating access and engagement with appropriate technical expertise.
  • Approval of the S3(UK) Engineering Authorities.


Skills

  • Working at a senior leadership level in the relevant areas for in excess of 10 years of experience is desirable. The role requires the need for particular skills in complex support and platform integration environments as well as awareness of the medical and training domains.
  • It is essential to be proactive with the stakeholders. Firmness and clarity in decision making is very important.
  • A broad engineering background is needed, and a sound knowledge of current relevant standards and in-house processes is needed. Detailed knowledge of product safety and regulatory standards are not essential.
  • A Chartered Engineer, a Member or Fellow of a recognised institution is desirable.
  • Demonstrate a culture of best practice sharing and knowledge.
  • Good coaching skills are highly desirable.
  • Good, clear, communication skills ? written and oral - are essential.
  • The ability to quickly grasp a complex set of circumstances to identify pragmatic solutions is essential
  • The role can be based at Edinburgh, Luton, Basildon, Southampton, Yeovil or Bristol.

Key Responsibility Areas

  • Act as the independent safety and technical authority for S3(UK) . Accept delegated authority to certify product designs on behalf of the Company, including those contracted under the Regulatory Articles.
  • Following appropriate training will accept delegated authority to act as "responsible person" for EU Declarations of Conformity.
  • Ensure the Integrity of S3(UK) products and projects, either directly or by delegation to an individual independent of the project hierarchy and with the required skills. Monitor the engineering governance process to provide recommendations for corrective action.Work closely with the QA organisation and the LoB to ensure that the products are being developed in accordance with the mandated requirements of the Development Lifecycle, compliant with contractual and legal requirements, are tolerably safe, and are fit for purpose.
  • Assure that any statement with respect to product compliance made on behalf of the Company, is independently verified.
  • Support the LoB's and IPTs by providing advice and clarification in planning product compliance, acting as Design Review chairman or assessor as appropriate, and facilitating access and engagement with appropriate technical expertise. Work towards optimising solutions.
  • Responsible for the approval, through a Competency Framework, of the LoB Independent Technical Authorities, Product Design Authorities and Design Review Chairs.
  • Understand, for the S3(UK) Product and Project Portfolio, the Design Approval Hierarchy for each product.
  • Support the LoB's and IPTs by providing advice and clarification in planning product compliance, acting as Design Review chairman or assessor as appropriate, and facilitating access and engagement with appropriate technical expertise. Work towards optimising solutions. Work across LoB's as required.
  • Ensure a culture of Best practice sharing and knowledge exploitation.
  • Contribute to the execution of the LoB Engineering Plans as required.

Skills, Qualifications & Knowledge Required

  • A broad engineering background is needed: while education and training might be in one discipline, the individual must have a wide engineering knowledge base. A sound knowledge of current relevant standards and in-house processes is needed. Detailed knowledge of product safety and regulatory standards are not essential.
  • A Chartered Engineer, a Member or Fellow of a recognised Engineering or Science Professional body is desirable.
  • Extensive experience of the development lifecycle of complex equipment, with a background in Engineering Management, is essential.
  • Intrinsic Factors
  • A high level of appreciation of the interaction of design with the Support environment is essential.
  • The ability to engage with the customer and business community at a senior level is essential
  • An enthusiasm for engineering (not just technology) is also essential.