Medical Devices Software Project Manager

Job description

The Software Project Manager position is a high-impact role for an experienced software engineer and project manager responsible for leading medical device development projects from initial concept to release.

As our Software Project Manager, you are responsible for the project planning, coordination and execution of activities to ensure that the goals and objectives of each project are accomplished within budget and time.

You are expected to make high level contributions to requirements specifications, requirements traceability, and improving the software development process.

You will be part of the Program Management Office (PMO) in a matrix organisation.

We are looking for exceptional candidates who can:

  • Plan and execute software development projects throughout product life cycle in accordance with established processes and procedures.
  • Lead and synchronize multiple software development teams and other internal groups and external partners to design, build, test, and release high quality software on scope, time and budget.
  • Drive development schedules and release planning, manage interdependencies between development teams, align software development with the system architecture plan, identify and manage critical software delivery risks.
  • Understand risk management in software and how software risk management connects with ISO 14971 Application of Risk Management in Medical Devices.
  • Demonstrate strong communication, organizational, and leadership skills, and an appropriate aptitude for user experience design, software architecture, software development and test methodologies, and hardware/software integration.
  • Work closely with the Quality Management organisation to ensure procedures are followed in accordance with the relevant regulatory requirements.
  • Build relationships with all subject matter experts, stakeholders, and senior management and escalate issues if required.
  • Routinely communicate project status to team, organization, and stakeholders.

Job requirements

  • Master’s degree or equivalent in computer science or related field.
  • Experience managing medical device software projects including knowledge of design practices required by FDA guidance and IEC 62304 Medical Software Life Cycle processes, is required.
  • Project management experience on new product development programs.
  • Project management experience on full-stack software applications.
  • Experience in managing 3rd party development partners.
  • Experience working within a phase-gate development process.
  • Experience working in an agile software development context.
  • Experience working with cloud technologies and mobile app developments is an advantage.
  • Ability to balance electrical, mechanical, and software development issues at the system level. Must have the ability to implement projects outside technical area of expertise.
  • Manage software product requirements and traceability matrix.
  • Manage technical partners/vendors supporting product development activities.
  • Ethical attitude and high integrity.
  • Highly proficient in spoken and written English. Knowledge of Dutch is an asset.
  • Experience setting up and using ALM tools such as Jira or TFS.
  • You thrive in a start-up environment and you can easily switch from one project to another.
  • Stakeholder-driven and customer focused, encourages a highly collaborative team environment and actively engages with all major stakeholders.
  • Results oriented, drives projects to closure and manages simultaneous projects in a fast-paced environment.
  • Flexible and stress resistant with very good planning and organization skills.
  • Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium.