Process Engineer

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Summary

Provide technical leadership in the validation, improvement, and control of manufacturing processes for Solid State MC (SSMC), Ion Chambers (ICX) and AmpMC. Ensure compliance with medical‑device regulations (MDSAP, ISO 13485) while driving quality, yield, and productivity improvements across all assigned product familiescoordinating the release of new products. Estimates manufacturing cost, determines time standards and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations.

Job Description

• Act as Process owner for Solid State MC (SSMC), Ion Chambers (ICX) and AmpMC.
• Establishes and maintains process windows including the FMEA, PCP, DOE execution and validation documentation (IQ/OQ/PQ) ensuring alignment with MDSAP/ISO standards.
• Initiate and drive process yield/capability improvements for new products (non-matured) and Process which includes Solid State MC (SSMC), Ion Chambers (ICX) and AmpMC.
• Responsible for:
  • Process validation (periodic and new/change in process)
  • Software validation (periodic and new/change in process)
  • TRFI updates
  • Return inspection PH
  • Return documentation PH
  • Return approval PH
  • Customer validation/acceptance process (PQP), and
  • ECR manufacturing support

• Leads RCA for NCMs, CARs, and MRB (process‑related).
• Provide technical support for daily production issues and act as escalation point for complex troubleshooting via VCNL Design Centre (DC).

• Conducts LEAN (VSM) analysis, course of actions implementation and follow-ups for the above Document and control of process-related - regular updating of manuals and TRIG's and ECRs, MDRs and other MDSAP related documents
• Defines equipment and tooling specifications; Purchase of equipment (coordinate with Competence Centre) thru CAPEX including the generation of business case and facilitates equipment specification definition and set- up management, qualification and release working with Manufacturing and Equipment/Maintenance Engineer.
• Provides input and technical review for changes (creation/update) in coordination to Manufacturing Engineering (ME) and/or Competence Centre (DC) of the following:
  • Material master, SAP BOM, SAP Routings
  • Labels and drawings
• Conducts training and examination on a regular basis for the above processes.

Typical Education and Experience

• Bachelor’s degree in electrical, Mechanical, Electronics Engineering, or related fields; licensed engineer preferred.

Experience:

Minimum five (5) years relevant experience in medical‑device manufacturing or a regulated industry. Experience in SSMC, Ion Chambers, AmpMC, Collimators, or equivalent high‑reliability product lines is an advantage.

Time Type:

Full time

Job Type:

Regular

Work Shift:

N/A

Pay Rate Type:

Salary

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.