Manager of software engineering állások Németországban (egészségügy, gyógyszeripar)

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

Austria and Switzerland commercial organisation, Third Party Distributors and relevant external agencies in the execution of the sales and business development strategy ensure accurate and efficient co-ordination and administration of all business...

• design hard- and software solutions to address intraoperative workflow problems of surgeons
• gather and integrate customer feedback to refine your designs
• build proof-of-concept demonstrators and test your solutions with product management and clinical partners

• Develop cutting-edge optical smart instruments and medical imaging devices, utilizing multiple optical sensing modalities with a focus on medical robotics applications
• Test concepts, core functionalities, and analyze data generated by optical sensing-based hardware and software

Conduct Interoperability Testing: Perform comprehensive testing of medical imaging devices and software to ensure compatibility and compliance with DICOM standards....

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Derive, structure, and prioritize user stories to guide development based on stakeholder requirements
• Coordinate interdisciplinary and cross-functional teams to implement new features effectively
• Guide and instruct the development team, managing technical dependencies to ensure smooth progress

• Coordination of the (partial) project to establish and continuously expand the EU reference network with all participating centres and clinics at EU level
• Participation in the helpdesk for the network's eHealth service
• Work with the project management team on the progression of the clinical registry

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....

• Technical responsibility in development projects in the field of Intraocular Lenses (IOL)
• Responsibility for the technical support of existing products throughout their entire lifecycle and assistance with approval in international markets

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams