Process Engineer

The Process Engineer provides engineering support for manufacturing equipment and processes used to produce plastic medical components. This role focuses on validating processes, equipment, and tooling, driving continuous improvement, reducing scrap, and optimizing capacity to support high-quality production in a regulated medical device environment.

• Support and lead project teams to increase productivity, reduce scrap, implement lean manufacturing practices, improve system availability, enhance safety, and elevate product quality, while prioritizing projects based on potential impact and risk.
• Develop molding and extrusion processes using scientific molding best practices and industry-established methods to ensure robust, repeatable, and efficient production.
• Write, review, and execute PVP, IQ, OQ, and PQ protocols and summary reports in alignment with cGMPs, ISO standards, and other applicable medical device regulations and specifications.
• Perform root cause investigations related to NCR and CAPA processes, report findings to cross-functional teams, propose corrective actions, implement approved solutions, and verify the effectiveness of those actions.
• Develop and maintain accurate and current standard operating procedures (SOPs) for equipment operation, part inspection, equipment changeover, and preventive maintenance activities.
• Prepare capital appropriation requests for new equipment to support manufacturing, including investment justification, vendor engagement for quotes, and identification of system specifications.
• Coordinate project timelines for new equipment and process changes to meet manufacturing needs and overall project requirements.
• Support manufacturing operations by diagnosing system or process failures and collaborating with Maintenance and Tool Room personnel to implement effective system fixes.
• Coordinate engineering expertise to identify and implement safety improvements that align with OSHA standards and promote a safe working environment.
• Collaborate closely with manufacturing teams to study, evaluate, and improve equipment and processes using data-driven analysis, design of experiments (DOE), and other applicable analytical methods.
• 3–5 years of relevant process engineering or closely related experience.
• Bachelor’s degree in plastic process engineering or a related engineering field.
• Education, training, and hands-on experience with plastics and plastic processing.
• Experience with equipment and processes used to manufacture, assemble, test, and package plastic components.
• Strong skills in process improvement and continuous improvement within manufacturing environments.
• Experience with plastic injection molding and related process engineering.
• Ability to support and lead cross-functional project teams and collaborate effectively with manufacturing, maintenance, and tooling personnel.

This role is based in a manufacturing facility that produces plastic components for medical devices within a highly regulated medical device environment. Employees may be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, and other workplace hazards that are controlled in compliance with current safety and health standards. The facility emphasizes advanced manufacturing, automation, and capital equipment projects, offering cross-functional collaboration and visibility to leadership.

The site serves as a center of excellence where engineers can drive meaningful improvements and see projects progress from concept to full production, contributing directly to life-saving medical devices and single-use endoscopy solutions.

This is a Contract to Hire position based out of Noblesville, IN.

The pay range for this position is…