South San Francisco
Employment Type: 
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We are seeking a Medical Device/Quality Engineer to join a global business and technology implementation project that is implementing a software solution (Siemens Polarion) to be used to manage Medical Device/Combination product design control activities.  The project is transforming the business process for development activities into digital workflow and digital documentation management.  This is a global project which includes team members and business stakeholders in the US and Europe. This role will be working with Device Team members in various roles in South San Francisco and Basel Switzerland to incorporate functionality of the Device Design Control Business process into the software.


The ideal candidate must have Medical Device/Combination Product development experience using procedural controls governed by 21 CFR Part 820 and EU MDR.  Experience in working on similar projects using Agile methodology is an advantage.  The candidate will also need to have flexibility to work in various time zones and have ability to travel to travel to Switzerland when needed, (after corporate travel restrictions are lifted).



Work with device engineering teams and cross-functional stakeholders to:

  • Evaluate and refine data models to that define business process and structure of deliverables that are used by Siemens developers to configure Polarion system interface
  • Develop new/improved processes necessary to maximize the efficiency of the software (eg. risk analysis, data and doc approvals, Design Reviews)
  • Identify and prioritize use-cases and product features that align with overall business and product strategy opportunities
  • Utilize AGILE implementation methodology to monitor product backlog and prioritization of product development initiatives, working closely with engineering teams to deliver final products
  • Conduct user acceptance and feature testing for software development SPRINTS and development releases
  • Consolidate user feedback and turn into technical solutions
  • Work with Product Teams to migrate data needed to conduct user acceptance testing
  • Work closely with team to develop training materials that will be used for onboarding new team members and for the GO LIVE rollout




  • 5+ years Medical Device Engineering experience for all phases of DHF development.
  • Prior experience using Device Design Control PLM tool within a regulated medical device/combination product industry.  Experience with Polarion is a plus.
  • Flexibility, willingness to learn, and a demonstrated ability to come up to speed quickly when working with new IT business applications and technical issues.
  • Must possess strong verbal and written communication skills

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