Project Engineer I - Injection Molding

Project Engineer I - Injection Molding Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings. 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. *Candidates must be legally authorized to work in the United States without current or future visa sponsorship* The expected salary range for this position is $70,000 to $80,000 annually, depending on skills, experience, and qualifications. Beverly, MA On-Site Freudenberg Medical LLC 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. Assist 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. Interfaces 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. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. #J-18808-Ljbffr Freudenberg Medical