Project Engineer I - Injection Molding

About the role

Support the development, documentation, and validation of manufacturing processes (e.g., extrusion, molding, assembly) in compliance with ISO standards, country-specific and GMP regulations.

Collaborate with cross-functional teams and customers to implement engineering initiatives, including standardization, continuous improvement activities, process improvements, and engineering change orders.

Aid in the design and qualification of tooling, fixtures, and equipment, including generating and executing IQ/OQ/PQ protocols as required.

Develop and maintain technical documentation such as BOMs, routers, manufacturing procedures, and work instructions.

Provide day-to-day engineering support on manufacturing processes, including troubleshooting issues as they arise.

Analyze test data, perform root cause investigations, and implement corrective actions to resolve quality issues and support CAPA/NCR activities.

Improve productivity and reduce scrap/reject rates through automation, tool/process improvements, effective training of production personnel and process enhancements.

Interface with customers and suppliers on project matters, mold and fixture design, validation, and product quality issues.

Responsibilities

• Support the development, documentation, and validation of manufacturing processes (e.g., extrusion, molding, assembly) in compliance with ISO standards, country-specific and GMP regulations.
• Collaborate with cross-functional teams and customers to implement engineering initiatives, including standardization, continuous improvement activities, process improvements, and engineering change orders.
• Aid in the design and qualification of tooling, fixtures, and equipment, including generating and executing IQ/OQ/PQ protocols as required.
• Develop and maintain technical documentation such as BOMs, routers, manufacturing procedures, and work instructions.
• Provide day-to-day engineering support on manufacturing processes, including troubleshooting issues as they arise.
• Analyze test data, perform root cause investigations, and implement corrective actions to resolve quality issues and support CAPA/NCR activities.
• Improve productivity and reduce scrap/reject rates through automation, tool/process improvements, effective training of production personnel and process enhancements.
• Interface with customers and suppliers on project matters, mold and fixture design, validation, and product quality issues.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field.
• 0-3 years experience in a regulated industry.
• Knowledge and exposure to injection molding, extrusion, and assembly, including the materials used such as plastic and silicone.
• Basic understanding of engineering terminology and manufacturing processes used in medical device production.
• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
• Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States).
• Basic understanding of process validation principles and reports, process window/repeatability studies, DOE’s, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.
• Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.
• Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records.

Benefits

• 401K Match: Save for retirement with the company's help.
• Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

Pay

The expected salary range for this position is $70,000 to $80,000 annually, depending on skills, experience, and qualifications.

Schedule

On-Site Freudenberg Medical LLC payments