Devops engineer m f d állás, munka

Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business....

• Perform release and stability testing of antibodies, proteins, and peptides using capillary electrophoresis techniques (e.g. CE-SDS, cIEF, CZE) in a GMP-compliant laboratory
• Conduct analytical method validations
• Document all work accurately in LIMS, Chromeleon and on paper

• Support MED-EL rehabilitation services world-wide
• Provide content and manage the hearing rehabilitation portfolio
• Develop and promote rehabilitation materials, tools, programs, and services for various platforms and media

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them

• Lead complex, data-driven engagements with international healthcare stakeholders
• Design and own project frameworks, KPI models, scoring methodologies, and implementation roadmaps in close collaboration with the Analysis and Data Science teams

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• Supporting system-related inquiries by analyzing and evaluating system errors and user requests for improvements and implementing solutions in collaboration with IT teams.
• Creating and revising work instructions.

KOL Engagement: Build and nurture strong relationships with key opinion leaders and healthcare professionals to support clinical development, product launches, and medical education. Represent the company at key industry events to expand our scientific influence....

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

• Lead and deliver workstreams within international healthcare benchmarking and transformation projects
• Co-develop project methodologies, KPI frameworks, and scoring logic in close coordination with the Analysis and Data Science teams

• Ramp up the practice together with the German holding company
• Comprehensive patient care including anamnesis, diagnostics and surgical planning
• Independent performance of liposuctions and surgical reconstructions after thorough training in our surgical home base Munich (Germany)