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Design and Development Process Engineer

Medical
Steinhausen

Together, we can beat cancer.At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. If you want to be part of this important mission, we want to hear from you.  Job Description

  • Lead and facilitate the identification, analysis, and implementation of Quality System process improvements and discussions, primarily on Design Controls. Engagement on a regular basis with global and cross-functional stakeholders and subject matter experts. This includes NC/CAPA related topics, Audit Findings, and internal requests or recommendations from product development teams.
  • Create, optimize, and/or update procedures, work instructions, guidance documents, and forms for processes covering Quality Systems, primarily on Design and Development (Design Controls). This includes creation of diagrams and process flowcharts.
  • Create or optimize training materials on existing or new processes with the audience being product development teams and leadership. Includes providing Instructor Led trainings and continuous support to project teams on ensuring compliance and understanding to design and development procedures.
  • Audit Representative for Design and Development topics and possibly other Quality System related processes and procedures in both Internal and External Audits. Applicable learnings and observations would be implemented by this role appropriately.
  • Support product development teams in using various Application Lifecycle Management tools to ensure accurate implementation and execution of Design Controls (as part of Design and Development process). May support creation of training material and the training of users on ALM tool usage to fulfill process requirements.
  • Support Quality System processes required for hardware and software medical and non-medical products/devices/components/services/tools.

   Job Requirements/Qualifications

  • Has worked in an environment that designs and manufactures medical product (hardware or software) and has a Quality System.
  • Has led and completed projects, improvement initiatives, NCs/CAPA investigations and mitigations, or other demonstrations of leadership capabilities.
  • Has authored Quality System documentation, such as procedures or work instructions.
  • Willing to accommodate different time zones for meetings and discussions (includes Asia, Americas, and Europe).
  • Can work remotely and in the office potentially 25% of the year. Includes International travel 5% of the year. May change depending on company policies related to Covid.
  • Has an Educational background in Engineering, Science, or related field.

 Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles. Fighting cancer calls for big ideas.We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.#TogetherWeFight Privacy Statement