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: Founded in 1978, Martech was best known as a supplier of high-quality extrusions and molded components. The company developed many secondary operations to support the further growth of our manufacturing operation. Recently Martech has continued expanding our capabilities to include CNC machining of precision machined components at our Pennsylvania location.
Martech provides concept to production services and support to the top medical device companies in the world. With three manufacturing and engineering facilities, over 2,000 employees and 200,000 square feet of manufacturing space we develop and produce the highest quality medical devices for use around the world. Our ability to complete projects, from small to large, uniquely positions Martech to serve all customers. Services that smaller companies do not have, or larger companies do not wish to spare, Martech can deliver and always works for you.

• 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