Process Engineer

Process Engineer (On-Site) 📍 Harleysville, PA Local candidates only.  This is a full-time onsite position.

Relocation assistance and employment sponsorship are not available for this position.

About the Role We are seeking a detail-oriented and innovative Process Engineer to join our on-site team.

In this role, you will be responsible for ensuring that all manufacturing processes comply with ISO, FDA, QMS, and other applicable regulatory standards.

You will evaluate and optimize existing processes to reduce costs, improve sustainability, and implement best practices across production operations.

Key Responsibilities Ensure compliance with ISO, FDA, QMS, and other regulatory requirements across all manufacturing processes.

Evaluate and improve manufacturing systems to enhance efficiency, reduce waste, and support sustainability goals.

Maintain safe and reliable production systems while improving :

• Production rates Process yields Changeover times Cost per unit Develop and implement process improvements and best practices.
• Perform testing, data collection, and analysis to support continuous improvement.
• Support validation activities including IQ, OQ, and PQ.
• Collaborate with cross-functional teams including Engineering, Quality, Tooling, and Operations.
• Assist in the design and implementation of tooling, fixtures, and manufacturing documentation (SOPs, work instructions).
• Participate in root cause investigations, corrective actions, and product / process transfers.
• Key Performance Indicators (KPIs) Process Yield Improvement   Downtime Reduction   Cost Savings from Process Improvements   Cycle Time Reduction   First Pass Yield (FPY)   On-Time Completion of Validation Activities   Number of NCRs / Complaints Resolved   Qualifications Bachelor’s degree in Engineering, Science, or a related technical field. 2+ years of relevant experience; internships or co-ops in manufacturing or medical device industry a plus.
• Familiarity with CAD and / or SolidWorks preferred.
• Proficiency in MS Office, SharePoint, PowerLink, MAPICS, and MS Project.
• Lean Manufacturing and Six Sigma Green Belt certification preferred.
• Must hold a valid passport for occasional travel to our Mexico facility.

About Us :

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