Process Engineer

Réalta Technologies are seeking a Process Engineer to support a Medical Device client of ours based in Raynham, MA, USA.

• 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.

• 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.