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Medical Device Development Engineer

2 months ago

Cambridge, United Kingdom Russell Tobin Full time

We are seeking a Medical Device Development Engineer for a prominent player in the pharmaceutical and medical device sector.

Role Overview:

This position requires a skilled mechanical or product development engineer to assist in the advancement of drug delivery medical devices. The responsibilities encompass various phases of device development, from gathering user requirements and evaluating vendor activities to validation, manufacturing transfer, and addressing complaints. A blend of technical acumen and planning expertise is essential to foresee and mitigate product risks. You will offer technical project support to identify and resolve product challenges while considering the needs of various internal teams.

Key Responsibilities:

  • Assist in the design and development of drug delivery devices.
  • Conduct risk management assessments and mitigation strategies, including DFMEA, contributing to UFMEA and evaluating critical functions.
  • Develop and substantiate requirement specifications for external suppliers.
  • Utilize theoretical engineering principles (e.g., forces, friction, mechanism analysis, materials) to analyze and critique design concepts and solutions, pinpointing critical functional areas, potential failure modes, and design sensitivities through both manual analysis and software tools.
  • Perform tolerance analysis using RSS or Monte Carlo methodologies.
  • Design test rigs and challenge components.
  • Manage initial usability studies to gather patient capabilities and preferences.
  • Create models and drawings utilizing 3D CAD software.
  • Conduct investigative laboratory testing to forecast design performance and acceptability.
  • Analyze test outcomes to assess design performance and acceptability.
  • Support supplier design evaluations and internal design reviews.
  • Generate documentation to facilitate medical device development and industrialization.
  • Engage effectively with suppliers and other internal teams.

Required Skills and Knowledge:

Essential:

  • Proficiency in CAD (preferably Pro-Engineer / Creo) and related document management systems.
  • Ability to perform engineering calculations such as free body diagrams, friction analysis, and beam bending.
  • Strong understanding of complex mechanical systems.
  • Experience with risk assessment tools, including FMEA.
  • Capability to manage and prioritize project tasks effectively.
  • Familiarity with quality management systems.
  • Ability to produce clear reports, documents, and presentations.
  • Excellent communication skills across various disciplines.
  • Strong critical thinking, problem-solving, and troubleshooting abilities.

Desirable:

  • Knowledge of ISO13485 standards.
  • Experience in user-centered design methodologies.
  • Familiarity with electro-mechanical systems.
  • Experience in designing with plastic components.
  • Understanding of injection molding processes.
  • Experience with Finite Element Analysis (FEA).
  • Knowledge of SolidWorks software.

Education and Experience:

  • Bachelor's degree in Mechanical Engineering or a related field.
  • Experience in the medical device industry is advantageous.