Job Description

Working at Freudenberg: We will wow your world!

Responsibilities:

• Lead the development, characterization, optimization, and validation of injection molding processes for new product introductions and manufacturing transfers.

• Serve as the technical owner for molding process development activities, ensuring processes are designed for stability, repeatability, quality, and efficiency.

• Apply Scientific Molding methodologies to establish process windows, define process controls, and optimize molding performance.

• Design, execute, and analyze Design of Experiments (DOE), mold characterization studies, process capability studies, and engineering evaluations.

• Develop and execute process validation protocols and reports, including IQ, OQ, and PQ activities, in compliance with applicable quality and regulatory requirements.

• Analyze process and quality data using statistical tools to drive data-based decision-making and continuous process improvement.

• Lead mold trials, engineering runs, process qualifications, and scale-up activities from development through production release.

• Partner with Tooling, Quality, Manufacturing, Validation, Supply Chain, and Project Management teams to ensure successful project execution and product launches.

• Provide technical input during Design for Manufacturability (DFM) reviews, tooling design reviews, and product development activities.

• Identify, investigate, and resolve complex molding process issues using structured problem-solving methodologies and root cause analysis techniques.

• Develop and maintain technical documentation, including validation protocols, technical reports, process specifications, engineering studies, and change control documentation.

• Interface directly with external customers to review technical requirements, communicate project status, support development activities, and provide technical solutions throughout the NPI process.

• Support project planning, resource coordination, timeline development, and risk mitigation activities to ensure project objectives are achieved.

• Mentor and provide technical guidance to engineers, technicians, and manufacturing personnel on molding process development and Scientific Molding principles.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Materials Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.

• Minimum of 7 years of experience in injection molding process development, process optimization, and validation within a manufacturing environment.

• Demonstrated expertise in Scientific Molding methodologies and their application to process development, troubleshooting, and validation.

• Intermediate to advanced English proficiency (B2+ or higher).

• Extensive experience conducting DOE studies, process characterization, process capability analysis, and statistical data interpretation.

• Strong knowledge of injection molding equipment, tooling, polymer processing, and engineering resins.

• Proven experience executing process validations (IQ/OQ/PQ) and developing technical documentation in regulated industries.

• Intermediate proficiency in SolidWorks for part, tooling, and manufacturability reviews.

• Intermediate to advanced proficiency in Minitab and statistical analysis techniques.

• Experience leading technical activities for New Product Introduction (NPI) projects and manufacturing transfers.

• Working knowledge of project management principles, project planning, scheduling, and cross-functional team coordination.

• Experience interacting directly with external customers and managing technical communications.

• Strong leadership, communication, analytical thinking, and problem-solving skills.

• Experience in the medical device industry or other highly regulated manufacturing environments.

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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.

Freudenberg Medical srl.