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
? 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
? 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