Christophe Schepens Email & Phone Number

North Ryde, Nsw, Au

Mechelen, Be

Resource and people manager of the Bio IT team. A highly skilled team of data scientists with a bio-informatician background and biostatisticians.I've introduced Agile Scrum to setup/organise the team backlog, to set priorities and to improve cross functionality. By means of the Sprint backlog and the task board, we're also able to balance the work load better over the team members and squads.Implemented a competence framework based on technical and behavioral competences and use it to define the different required roles and job levels in a team. Next to that, the competence framework is used to setup individual training and career development plans.Use of Agile Scrum & competence framework to scale and divide the team into Squads. This in line with Biocartis needs, team expectations and motivations.I've initiated and built sustainable relations with complimentary external partners that help us by providing embedded consultants in our team, or directly offload work by means of outsourcing.Responsible for yearly budgeting of the team, including price negotiations of tooling licenses.Responsible for yealy cascading and follow up of company objectives into team and individual objectives.Stimulated the team to adopt new technologies like Azure, Databricks, Docker and Nextflow.I succesfully lead the software part of the 510K clearance of the Biocartis MSI product which involved addressing deficiencies identified by the FDA, updating our DHF accordingly and responding towards the FDA. I've provided similar regulatory support for the NMPA (China) submission of Biocartis' diagnostics tests and platform.Responsible for the software validation of the medical SW released by the team, as well as the in house developed used tooling.Next to that, I'm a process owner and accountable for the execution of the processes in the team. I'm very knowleadge of ISO62304 and FDA's Content of Premarket Submissions forDevice Software Functions.

Mechelen, Be

Software project manager for various projects in the Idylla™ eco-sphere:- Console software (IVD, IEC62304 class C) releases, used to operate the Idylla system- Instrument software (IVD, IEC62304 class C) used to perform the test- Internal customer support web application, using IoT to send and retrieve information from the Idylla™ platforms- Idylla™ Explore, a web-based application used internally at Biocartis and by customers to have easy access to test results OQ cartridge project, a cartridge used to operational qualify the Idylla™ instrument after manufacturing, repair, service and refurbishment. As a PM I was responsible for:- SW updates on the system to support the OQ cartridge usage- Development of the cartridge with biochemicals- Transfer of the cartridge to the cartridge manufacturing line- Transfer of the OQ cartridge to Instrument manufacturing line, service engineers and key account managers Other:- Introduced Agile Scrum from scratch, for all software projects above- Established a PM expert circle for all Biocartis R&D PM’s to share knowledge and experience; streamline PM tools- Lead the validation of many updates on the Console, Instrument and Idylla™ Explore SW.- Make sure risk-based scaling is applied for non-medical SW projects, to build in extra quality controls where needed- Co-author of the internal SW development process for non-medical software- Introduced trainings to the users to inform them on the SW updates and their impact- Manage stakeholders and communication towards stakeholders- Regular traffic light/dashboard reporting to local management- Author of software development plans and product development plans- Author of validation plans and validation protocols- Facilitated various lessons learned sessions and retrospectives (on project and team level)

St Petersburg, Florida, Us

Software project manager for a medical device:- Maximum team size 7 persons- Make sure medical processes are applied (IEC 62304, ISO 13485, ISO 14971 for FMEA)- Requirements traceability- Problem report and change request management- Communication with end customer, making customer satisfaction a priority- Regular traffic light reporting to local management- Software process championLead software engineer/project manager of a diagnostics tool.Team size up to 12 persons.- setup multi site project (Belgium, China, USA)- create project descriptions (including scope, schedule, budget, ...)- track budget and schedule- track problems and change requests- communicate with customer- co-develop diagnostic modules and user interfaceLead Software engineer of an automatic front end measurement system. Team size up to 5 persons.- creating project descriptions- track the budget and schedule- control change requests- participate in codingFollowed course IPMA-D at Amelior to improve project management skills.

St Petersburg, Florida, Us

Embedded Software engineer for Consumer Electronics.Implemented an automatic test system for digital front ends to do validation and pre-compliance tests. Some key features:- Supported digital standards: DVB-T, DVB-C, DVB-S, DVB-S2 and ATSC- Some test cases: minimum input level, maximum input level, implementation loss, co-channel, adjacent channel etc- Automatic excel reporting and validation against the specification

St Petersburg, Florida, Us

- Design of schematics and lay-out for PCB's (printed circuit boards) and peripherals for mobile phones and LCD-TV- Electrical verification measurements of the designed PCB's- Production support when designed product is transferred to mass production (Hungary, Poland, China)- Follow up and verify the design of suppliers (PSU for LCD-TV, cables for LCD-TV etc)- design lead for PSU of LCD-TV- Give training and demonstrations

St Petersburg, Florida, Us

- Embedded software Engineer on TriMedia based chipsets (Audio/Video DSP)- Developed software to stream audio and video over HTTP or RTP (wireless and wired)- Developed Diagnostic Software (DSW) - All in C

Amsterdam, Noord-Holland, Nl

- Embedded software Engineer on TriMedia based chipsets (Audio/Video DSP)- Developed software to stream audio over HTTP (wired)- This involved a lot of TCP/IP socket programming on TriMedia based chipsets- All in C

Industrial Engineer, Electronics (Ict)

Industriële Wetenschappen

Basisopleiding Projectmanagament

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