Software development Engineer - Medical Devices

Details

  • Category: Medical devices
  • Location: Lausanne
  • Starting date: Nov 01, 2018
  • Domain of experience: Software Development
  • Level required: Middle
  • Years of experience: 4

Your Role

As a member of the engineering team, the Software Development Engineer will be responsible for:
  • The architecture, design, development, coding, debugging, testing, maintenance and verification of the software for the BINJ products
  • Support the on-going projects and development activities including working closely with external suppliers
  • Gathering, understanding and analyzing product requirements and translate them into implementable design inputs for BINJ Software products
  • Delivering the software and system work packages and owns all the related phases of the software development lifecycle
  • Planning and executing Software Verification and Validation as part of software development projects
  • Authoring and maintaining technical documentation required for CE marking and FDA approvals in compliance with regulatory requirements
  • The continuous improvement of software quality, reliability, and safety

Your Tasks

  • Specify, design, develop, code, master the software release and maintain the software for the BINJ products
  • Specify, develop and maintain the deployment procedure of the software applicative
  • Assure systems interoperability, conformance to communication standard, data protection and compliance to data privacy policies
  • Collaborate with external development teams for the integration of our product with other software solutions
  • Participate to verification and validation effort, ensure efficient, robust and high coverage test strategy
  • Author, improve or review software documentation (including specifications, design and verification documents) by focusing on quality, reliability and safety of BINJ software products, as well as compliance with relevant standards (IEC62304, FDA Guidelines)
  • Report and provide workload estimations
  • Make recommendations for design enhancements, conduct feasibility studies and technical investigations, assessments, and technical surveys
  • Stay up to date with the latest standard on technologies and security good practices
  • Collaborate with Quality and Regulatory team for impact analysis, software risk or quality assessment and provide support in case of audit
  • Provide last level customer support, and propose solution to customer complaints
  • Make propositions and contribute to the R&D process optimization
  • Contribute in the definition, implementation of best development practices: KPI definition, Software Quality metrics, and continuous alignment on applicable standards

Your Profile

  • MSC or Ph.D. in Software Engineering or Computer Science or equivalent
  • Knowledge in SW dev processes according to Medical Devices Regulation and standards in US and EU
  • Relevant experiences in software development and modular architecture design (UML, SOA, design patterns)
  • Proficiency in C++, C# / VB .Net, SQL with expertise in multitasking, multithreading, object-oriented programming
  • Entity Framework, hibernate
  • Web-based responsive application development and testing, web services
  • Strong documentation and writing skills and ability to follow Quality and Regulatory requirements, prepare DHF and Technical Files
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