R&D Technical Manager

15 Oct 2021
12 Nov 2021
Martin Taggart
Job Type

R&D Manager (Part Time - 12 Months)
Job Description
Main Duties/Responsibilities

  • Manage the R&D team responsible for MDR remediation and sustaining activity of existing products.
  • Provide Technical direction to team critically analysing and distilling applicable requirements into clear goals & objectives for all Team members.
  • Work as member of site MDR steering Team to plan, organise and review site MDR program activity ensuring that progress is maintained to achieve submission approval milestones and business continuity.
  • Liaise and work effectively with Sales & Marketing, Regulatory, DA, QA, Operation, Planning and other critical functions to form a cohesive project Team ensuring all inputs and requirements are considered, included in project scope.
  • Organise and provide direction and input on execution of design control activities such as User requirement review, risk analysis, product specification, Human Factors analysis, test method development/validation and Design Verification & Validation in order to successfully bring product to regulatory submission stage.
  • Organise, review and sign off required Engineering and Design documentation in line with the Quality Management System and associated regulatory requirements.
  • Foster an environment of continuous improvement in all aspects of R&D from design systems& documentation through to technology and process development.
  • Performs other related duties and tasks as required.

Minimum Qualifications/Competencies:

  • Degree in Engineering, Science, or related technical field or with appropriate demonstrated experience.
  • At least 10years previous related experience in med device product development with a minimum of 5 in a technical personnel management role.
  • Experience in interpretation and application of MDR requirements in Med Device development.
  • Strong interpersonal and organizational skills and the ability to work effectively as a team leader.
  • Demonstrated analytical problem-solving and innovative thinking.
  • Good working knowledge of medical device materials and processes.

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