Sr. Manufacturing Engineer

Working at Freudenberg: We will wow your world!

Responsibilities

Direct the development, optimization, and validation (IQ/OQ/PQ) of processes using scientific and data-driven methods (DOE, FMEA, SPC) in compliance with ISO standards, country-specific and GMP regulations. Lead, generate, and maintain technical documentation including BOMs, work instructions, procedures, validation protocols, inspection criteria, and quality records in compliance with quality system requirements.

Establish and maintain strong cross-functional teams to evaluate, develop, and manage sustaining engineering projects. Serve as the engineering liaison between production, quality, suppliers, and customers. Drive Lean/Six Sigma projects to improve productivity, quality, delivery, and cost; oversee Kaizen initiatives and eliminate waste in manufacturing processes.

Design, evaluate, and implement tooling, automation, and equipment improvements; oversee capital projects and new technology integration to enhance manufacturing capabilities. Lead project planning and execution using APQP tools; manage EO/DCN changes and ensure proper implementation and documentation across engineering and production.

Monitor and improve key KPIs such as OEE, yield, and downtime; develop accurate cost models, drive cost reduction initiatives, and support make/buy decisions. Provide advanced troubleshooting and leading implementation of permanent corrective actions for manufacturing issues as a subject matter expert. Formally train junior staff or acts as a resource for colleagues with less experience.

Qualifications

Bachelor's/University degree in Engineering or related science/technical field. 5 - 8+ years’ experience in a regulated contract manufacturing medical device industry. Thorough understanding of manufacturing processes used in medical device production, such as running equipment, catheter manufacturing, and complex assembly, including the materials used.

In-depth knowledge of manufacturing equipment and automation systems, and the ability to optimize their utilization along with fixturing. Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills. Extensive knowledge and understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.

Extensive 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). Deep understanding of process validation principles and process window/repeatability studies, DOE’s, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.

Mastery of product testing and inspection methods, including developing test protocols and overseeing testing activities to ensure compliance with specifications and standards. Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records. Advanced skills in root cause analysis and problem-solving to identify and address complex manufacturing issues.

Demonstrated experience implementing continuous improvement methodologies and lean manufacturing principles to optimize efficiency and reduce waste. Advanced skills in using SPC tools and statistical data analysis to monitor and improve manufacturing processes. Strong English skills to work with internal teams and external customers.

‎ ‎ 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.