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Senior Mechanical Design Engineer

2 mesi fa

Roma, Lazio, Italia Bvi Medical A tempo pieno

About the Role:

We are seeking a highly skilled Senior Mechanical Design Engineer to join our team at Bvi Medical. As a key member of our RD Team, you will be responsible for the design and development of mechanical systems and products for ophthalmic surgical devices.

Key Responsibilities:

  • Design and develop medical device components, sub-assemblies, and complete systems, as well as associated test and fabrication fixtures.
  • Define test methods and conduct testing of complex mechanical systems.
  • Interface with internal and external suppliers, manufacturers, and customers.
  • Generate detailed part and assembly drawings while applying GDT techniques and perform tolerance analysis of complex assemblies.
  • Work collaboratively with project teams (e.g., Quality, Regulatory, Manufacturing, and Service) at all stages of development and through product lifecycle.
  • Support of Quality teams in ensuring GxP and other activities (e.g., complaints root causing and resolution).
  • Support of Regulatory team with technical documentation as mandated by authorities.

Requirements:

  • Ability to use knowledge of fundamental physical laws and quick back-of-the-envelope calculations to quickly assess design challenges.
  • High level of proficiency in 3D modeling software (Solidworks, and/or Creo preferred) for mechanical design.
  • Experience with TDD methodologies.
  • Experience leveraging rapid prototyping materials and technologies for fast prototype build and design iteration.
  • Knowledge of applicable materials, manufacturing methods, and engineering industry standards and specifications.
  • Knowledge of plastic part design and materials for high volume part production.
  • Knowledge of ISO, regulatory, and legislative standards applicable to the development of medical devices (e.g., FDA, MDR, 13485 etc.).
  • Effectively utilize problem-solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities.
  • Excellent interpersonal and communication skills with all levels of associates, management, and external partners.
  • Hands-on experience with common metal-working and assembly tools.

Education and Experience:

  • Bachelor's degree in engineering or equivalent years of directly related experience.
  • Medical Device Experience preferred.
  • Fluent English and Italian.