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Sustaining System Engineer - Critical IT infrastructure and accessories for medical devices

Job Description

We are looking for a Sustaining Systems Engineer that will be responsible for cross-functional collaboration and execution across technical and non-technical teams throughout the product development lifecycle, and serves as a key interface with product managers and engineers from every discipline with a specific focus on sustaining the critical Information Technology infrastructure and accessories required to support the Pathology Instrumentation portfolio.

The position is located at our Danish site in Glostrup.

Job responsibilities:

Specific tasks and responsibilities include, but are not limited to:

Driving critical sustaining engineering activities:

  • Initiation and execution of engineering changes to complete key sustaining/maintenance.
  • Leading performance of product care projects/activities.
  • Coordination and leading activities related to hardware enhancement and in-sourcing projects.
  • Planning and execution of R&D activities in projects/sustain activities incl. resource estimation.
  • Creation and updates of product parts and intermediates.
  • Definition of specifications for Instrument Information Technology Infrastructure and Accessories:

  • Alignment of stakeholder needs for impacted instruments and accessories.
  • Creation of detailed requirements of critical features.
  • Establishment of verification strategies to confirm implementations.
  • Leadership of third-party vendors in Operating System build process.
  • Executing on key Quality processes:

  • Initiation and ownership of CAPAs.
  • Managing and performing customer request/complaint investigations.
  • Performance of root cause analyses -- both covering technical or quality problems.
  • Performance and Management of Design Control activities:

  • Planning, generation and update of Design Control (e.g. DHF and DMR) documentation according to QMS.
  • Plan and execute testing as part of verification.
  • Use of statistical tools to reduce test plan complexity.

  • Driving Continuous Improvement initiatives:

  • Ongoing monitoring and awareness of new regulations and guidelines within IVD Instrumentation.
  • Improvement of Pathology QMS within R&D work span.
  • Improve internal work processes and efficiency.
  • Implement and develop visual planning tools and principles.

  • Qualifications

    Your qualifications:

  • Bachelor's or Master's degree in engineering or related disciplines.
  • Relevant job experience -- preferable from a similar role.
  • The ideal candidate will have experience in creation of complex systems through verification and validation as well as post-launch and on-market product support.
  • You have experience with design controls incl. requirements engineering, design verification, change control, product risk management and documentation.
  • Strongly desired that you have experience from the regulated industry (eg. Medical Device, IVD or Pharma)
  • You will work in an international environment, hence solid skills in English (both written and spoken) are a must.
  • In addition, you are preferably skilled in root cause analysis or have an interest to work with this.
  • On a personal level you must be good at driving your activities while communicating and coordinating with various stakeholders within the organization. You are dedicated and driven by results, which you reach by working independently and with your colleagues within organization.

    You are well-structured and have a systematic way of working, seeking simple and effective proactive solutions within the complexity that surrounds a medical device and the accompanying documentation package. You can work with day-to-day deadlines and changing priorities, as well as in projects with longer duration.

    To have success in this role, you must be a self-starter and motivated to drive projects to completion. You excel at managing multiple priorities and projects at once.

    Hiring manager:

    You will be reporting to Rick Dochterman, Senior Technology Manager in the Software Department located in California, US .

    Ques tions:
    If you have any questions to the position

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