Mechanical Engineer in R&D Department

6 dni temu

Poznań, Greater Poland LiNA Medical ApS Pełny etat

LiNA Medical Polska Sp. z o.o. – manufacturer of medical devices in the field of minimally invasive gynecologyis looking for: Mechanical Engineer in R&D Department

Responsibilities:
  • Participate and be a key player in the development of LiNA's new medical devices and support maintenance of released products.
  • Design and be one of our key Mechanical Designer in various NPD projects.
  • Create and maintain 2D and 3D documentation during development phases, including updates related to product changes.
  • Design parts, test setups, and necessary manufacturing setups for our products.
  • Involve in and be responsible for pre-engineering and verification testing related to design control requirements.
  • Support the risk management team.
  • Participate in and occasionally lead change request activities.
  • Engage in problem-solving activities, root cause analysis, and NC & CAPA processes.
  • Analyze the state of the art for similar products and assist in defining input requirements for projects, ensuring compliance with relevant safety standards (e.g., IEC 60601-1, ISO 10993).
  • Support and prepare quality and technical documentation related to design, development, testing, and regulatory purposes.
  • Collaborate with cross-functional departments, clinical experts, regulatory officers, technical consultants, and suppliers.
Requirements:
  • Minimum of 3 years of experience in R&D or a similar field, preferably in the medical device industry (5+ years preferred).
  • Master's degree or equivalent in engineering (preferably Mechanical or Mechatronic Engineering, Biomedical Engineering).
  • Extensive experience with Creo, and ideally also with SolidWorks.
  • High level of experience in designing small metal and plastic parts, with knowledge of injection molding.
  • Familiarity with relevant industry standards (e.g., ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607, ISO 10993) is preferred.
  • Strong organizational skills and a high sense of ownership.
  • Enthusiasm for hands-on device testing and prototyping.
  • Ability to work effectively in teams and prioritize tasks.
  • Proficiency in English (speaking, reading, and writing at B2 level or higher).
We offer:
  • The opportunity to develop cutting-edge technology that saves lives.
  • Work in the R&D department within an international, interdisciplinary team.
  • Interesting technical challenges.
  • A great office atmosphere.
  • A range of benefits, including private medical care, sports card, flexible working hours, and English lessons.

Please add the following clause: I consent to the processing of my personal data for the purposes of the recruitment process (in accordance with the Act of May 10, 2018 on the protection of personal data (Journal of Laws of 2018, item 1000) and in accordance with the Regulation of the European Parliament and Council (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46 / EC (GDPR)).

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