Mechanical Engineer in R&D - Medical Devices

About the role

LiNA Medical Polska, a manufacturer of medical devices in the field of minimally invasive gynecology, was looking for a Mechanical Engineer for its R&D department in Poznan. The application period has ended and this is now an archived listing.

Key responsibilities

• Take part in developing LiNA's new medical devices and help maintain released products.
• Act as a key mechanical designer in various new product development (NPD) projects.
• Create and maintain 2D and 3D documentation, including updates for product changes.
• Design parts, test setups and manufacturing setups.
• Be responsible for pre-engineering and verification testing linked to design control requirements.
• Support the risk management team, take part in and occasionally lead change requests, and contribute to root cause analysis, NC and CAPA processes.
• Analyse the state of the art of similar products and define input requirements in line with safety standards such as IEC 60601-1 and ISO 10993.
• Prepare quality and technical documentation for design, development, testing and regulatory purposes.
• Collaborate with cross-functional departments, clinical experts, regulatory officers, technical consultants and suppliers.

Required profile

• At least 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, Mechatronic or Biomedical Engineering.
• Extensive experience designing small metal and plastic parts, with knowledge of injection moulding.
• Familiarity with standards such as ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607 and ISO 10993 is preferred.
• B2-level English (speaking, reading and writing).

Required skills

• Creo (extensive experience); SolidWorks is ideal.
• Hands-on device testing and prototyping.

What we offer

• Work in an international, interdisciplinary R&D team with interesting technical challenges.
• A range of benefits including private medical care, sports card, flexible working hours and English lessons.