Product Engineer

4 settimane fa


Milan, Italia Page Personnel A tempo pieno
  • Design, develop, and implement engineering solutions across cross-functional teams.
  • Identify product requirements based on indications deriving from clinical research, regulatory requirements, and marketing.
  • Develop prototypes by applying the technologies accessible to the organization.
  • Define product specifications, and drawings and bill of materials.
  • Improve design product and process, prototype, DHF documentation drafting and issuing.
  • Propose and define Test Methods for measuring and verifying the properties of materials, systems and devices, including Quality Controls.
  • Identify solutions for complex technical issues and product improvements.
  • Ensure that product designs meet specifications.
  • Analize component and product non-conformities, providing root cause analysis and suggested actions.
  • Work with process development engineers to ensure that products are optimally designed for manufacturing. Create specifications for device components and assemblies.
  • Implement verification and validation activities.
  • Prepare documentation for technical meetings with the team.
  • Build partnerships with the project's stakeholders (both internal and external), leveraging them to achieve organizational goals and able to negotiate effective solutions.
  • Master's degree in Biomedical engineering or relevant discipline.
  • >5 years of relevant experience to related position and in Medical Device industries.
  • Product Life Cylce system, Design Control and related applicable ISOs and guidelines, and Product Development experience.
  • Direct experience in medical device design and development (Class III and / or Implantable devices).
  • Knowledge of regulatory requirements and quality standards applicable to medical device development and manufacturing, such as FDA 21 CFR Part 820 and ISO 13485 is a plus.
  • Fluent in English, written and spoken.
  • Strong analytic and problem-solving skills, ability to understand company processes.
  • Strong interpersonal skills, with the ability to collaborate effectively with diverse teams.
  • Positive attitude during challenging situations.
  • Good communication skills.

Permanent contract

Product Engineer - Medical Devices



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