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Realta Technologies

1 job near Columbus, OH

Realta Technologies

Process Engineer (420)

Raynham, MA · On-site

Réalta Technologies are seeking a Process Engineer to support a Medical Device client of ours based in Raynham, MA, USA. Job Responsibilities * Lead process engineering activities to deliver safe ...

Process Engineer (420)

Realta Technologies

Raynham, MA • On-site

Full-time

Posted 2 days ago

Job description

Réalta Technologies are seeking a Process Engineer to support a Medical Device client of ours based in Raynham, MA, USA.
Job Responsibilities
  • Lead process engineering activities to deliver safe, compliant, and efficient manufacturing operations.
  • Drive continuous improvement in throughput, yield, OEE, and cost using Lean and Six Sigma methodologies.
  • Identify and eliminate process bottlenecks through structured problem solving and data-driven analysis.
  • Develop and execute process validation and equipment qualification (IQ/OQ/PQ) in line with regulatory requirements.
  • Support new product introductions and technology transfers, ensuring robust and scalable manufacturing processes.
  • Define and maintain process control strategies including PFMEA, control plans, and standard work.
  • Provide day-to-day manufacturing support, troubleshooting issues related to quality, downtime, and performance.
  • Apply statistical tools (DOE, SPC, MSA) to establish process capability and drive corrective/preventive actions.
  • Collaborate cross-functionally with Operations, Quality, Maintenance, and R&D to ensure reliable production.
  • Support equipment and automation improvements, including vendor engagement, commissioning, and process optimisation.

Job Requirements
  • Bachelor's degree in Mechanical, Industrial, Manufacturing, Chemical, or related Engineering discipline.
  • 3+ years' experience in process/manufacturing engineering within a regulated environment (Medical Device preferred).
  • Strong experience in process development, optimisation, and validation (IQ/OQ/PQ).
  • Solid understanding of GMP/ISO standards and regulatory compliance (FDA/European experience desirable).
  • Proficiency in Lean/Six Sigma methodologies and statistical tools (DOE, SPC, MSA, root cause analysis).
  • Strong technical knowledge of manufacturing equipment, tooling, and process controls.
  • Data analysis capability using tools such as Minitab, JMP, or Excel.
  • Experience working with MES/ERP systems and basic CAD familiarity.
  • Proven ability to troubleshoot complex process issues and drive effective solutions.
  • Strong communication, stakeholder management, and cross-functional collaboration skills.

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