System Engineer Consumables

Location München, Bayern
Job type Permanent
Salary Negotiable
Start date ASAP
Contact Maximilian Köckeis
Job ref M0017_1612975076

Job description

Your Tasks:

  • Development and maintaining of a portfolio of consumables for use with femtosecond lasers in ophthalmology, including requirement specification and design verification / validation
  • Manage design transfer to manufacturers and have control over IQ / OQ / PQ
  • Maintain close communication and collaboration with internal departments (procurement, service, production, validation, quality and regulatory) as well as external development partners and suppliers
  • Push project tasks independently by collecting required information for design input and output.
  • Manage design process and required technical documentation activities according to internal standards.
  • Technical support for current and future business to ensure the ability to deliver products and services to customers.
  • Lead investigations and root cause analyses. Focus on constant improvement of product quality and costs.
  • Proactive input of ideas and projects into development pipeline.
  • Presentation and communication to project management and other internal stakeholders as well as to national and international partners.

Your profil:

  • Technical or Scientific University Degree
  • At least 3 years of professional experience in the development of medical products, especially sterile disposable products.
  • Solid experience and state-of-the-art knowledge of the Design Control Process for Medical Devices according to MDR and MDSAP requirements
  • Experience in product and process validation of sterile disposable products for worldwide registration
  • Expertise in the following standards is advantageous:
  • ISO 14971: Medical devices - Application of risk management to medical devices
  • IEC 62366: Application of usability engineering to medical devices
  • ISO 11137: Sterilization of health care products
  • ISO 11607: Packaging for terminally sterilized medical devices
  • Very good German and English skills, both written and spoken
  • Practice-oriented and autonomous working method

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