For our customer located in Basel/Switzerland we are currently looking for a: Connected Health Operations Engineer (m/f/d)
- Location: CH-4056 Basel
- Branch: pharma
- Duration: 10 monts +
Tasks & Responsibilities
The Connected Health Ecosystems & Operations team is looking for an Operations Engineer to ensure the smooth transfer of Connected Health products from Development into Operations and the establishment of technical support at a global and country level for clinical trials and commercialized products. The Operations Engineer will support issues arising for products in use, which may include connected drug delivery devices, mobile apps, and services running on cloud storage systems.
This highly interactive role will work with cross-functional teams across the company to create the documents needed for digital operations, such as the operational handbook and disaster recovery, business continuity and data back-up plans. In addition, they will create and maintain the technical support processes for 1st, 2nd and 3rd level support with interfaces to adverse event and technical complaint processes in a systems engineering modelling tool, and document and test these processes for each asset prior to launch. This will require working with global and country level support services, as well as IT services.
- Conduct transfer of Connected Health products into operations, working with key stakeholders in IT and Manufacturing to ensure Digital Operations and Device Manufacturing documentation is written as required
- Work with global and local technical support services to establish the L1, L2 and L3 technical support services. Ensure transfer of product design information to each level to create necessary support materials such as FAQs
- Ensure support services interface with Adverse Event and Technical Complaint processes
- Create the documents needed for digital operations, such as the operational handbook and disaster recovery, business continuity and data back-up plans, according to timelines and design control process
- Use model based system engineering tools, such as Enterprise Architect, to describe the different processes and information flows
- Identify different use case scenarios and use these to validate the processes
- Monitor released products and drive continuous improvement in processes and updates to materials
- Lead root cause investigations and drive change control processes
- Manage and track all activities triggered after released of a product (e.g. security update, ios update, simple stakeholder change…)
• Author relevant design history files and GMP compliant documentation.
- Systems and process design using UML/SysML diagrams with good abstraction skills
- Expertise in the life-cycle management of medical devices, especially complicated products involving medical device software with mobile apps and cloud-storage systems
- Expertise in documents required to maintain commercialized medical device software products
- Detailed documentation of processes
- Fault tree analysis, identifying use cases and validating processes in real world scenarios
- Expertise in technical support for at scale for a global organization a plus
- Root cause investigation, change management processes
- Excellent problem-solving skills with an analytical mind
- Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines
- Minimal 5 years of experience in medical device development, or other highly regulated industries
- Strong communication skills for both technical discussions with dev team and also for alignments with business stakeholders
- Prior experience covering the medical device and/or SaMD product development from concept to commercial launch
- Experience working with the requirements and traceability management tools
• Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.
Preferred Interview Dates