Sr. Manufacturing Engineer

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.

Some of your Benefits Cafeteria/ Canteen: We offer fresh food on-site, both hot and cold.

Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.

Alajuela

On-Site

Freudenberg Medical srl.

You support our team as

Sr. Manufacturing Engineer 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.