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Manufacturing Process Engineer

Company: Varian
Location: Palo Alto
Posted on: January 12, 2022

Job Description:

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.

Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Assists in equipment selection, and specification. Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols. Also serves as information resource for validation technicians, contractors and vendors.

  • Leads projects in optimizing the efficiency, capability and effectiveness of manufacturing processes through strategic process improvement.
  • Closely collaborates with Manufacturing, Manufacturing Engineering and New Product Introduction (NPI) in planning and execution of Validation activities of Manufacturing processes and equipment in Manufacturing Operations/Production.
  • Active participation in defining activities to assure compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, ISO 13485, MDSAP, MDD and EU MDR).
  • Manages Validation projects, manufacturing risk analysis, process control plans and performs validation activities, including developing of validation plans, protocols (IQ/OQ/PQ/TMV) and reports as well as Validation process procedures and other Quality System documentation. Maintains all documentation pertaining to qualification and validation.
  • Design and perform process characterization studies & DOEs to develop new and/or improve existing assembly processes with Manufacturing/Industrial Engineers. Support data trending and implement statistical process controls for processes by selecting parameters that impact product quality.
  • May be assigned to action items related to NC or CAPA
  • Experienced in problem solving techniques involving Lean/Six Sigma statistical tools such as Minitab
  • Experienced in using Lean Management Tools: Kaizen, 6S, Kanban.
  • Supports and as required, participates in Quality System audits. Serves as information resource for Production and Manufacturing Engineering
    Minimum Required Skills And Knowledge
    • Prior medical device experience preferred i.e. Experience working with and understanding Quality System requirements in the medical device industry, such as GMP, 21CFR820, ISO 13485:2016, EU MDR.
    • Experience Level with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
    • Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.
      Typical Education And Experience
      • Bachelors Degree (or equivalent experience) and/or 2-5 years of related experience or Masters Degree with no or little experience.
      • Serve as a mentor to others.
      • Effective interpersonal skills Work with peers throughout the organization and be effective in engaging resources. Ability to leverage and/or engage others to accomplish projects.
      • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
      • Ability to work with geographically diverse and international teams.
      • Multitasks, prioritizes, and meets deadlines in timely manner.
      • Strong organizational and follow-up skills, as well as attention to detail.
        To ensure compliance with applicable legal requirements in the U.S., including the federal COVID-19 vaccination mandate, all U.S. employees must be fully vaccinated for COVID-19, subject to legally required and approved accommodations .

        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.


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Keywords: Varian, Palo Alto , Manufacturing Process Engineer, Engineering , Palo Alto, California

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