Sr. Manufacturing Engineer

About the role

Freudenberg Medical, a trusted CDMO for medical devices and pharmaceuticals, is looking for a Senior Manufacturing Engineer to lead process development, optimization, and validation. The role focuses on applying scientific, data‑driven methods to ensure compliance with ISO standards and GMP regulations.

Key responsibilities

• Develop, optimize, and validate manufacturing processes using DOE, FMEA, SPC and ensure IQ/OQ/PQ compliance.
• Create and maintain technical documentation such as BOMs, work instructions, validation protocols, and quality records.
• Lead cross‑functional teams on sustaining engineering projects and act as the engineering liaison between production, quality, suppliers, and customers.
• Drive Lean/Six Sigma and Kaizen initiatives to improve productivity, quality, delivery and cost.
• Design, evaluate and implement tooling, automation, and equipment upgrades; manage capital projects and new technology integration.
• Monitor KPIs (OEE, yield, downtime), develop cost models and support make/buy decisions.

Required profile

• Bachelor’s degree in Engineering or a related technical field.
• 5–8+ years of experience in regulated contract manufacturing of medical devices.
• Deep knowledge of ISO 13485, ISO 14001, ISO 14971 and GMP (including 21 CFR 820).
• Extensive experience with process validation, DOE, IQ/OQ/PQ and statistical process control.
• Proven ability to lead continuous‑improvement projects using Lean and Six Sigma methodologies.

Required skills

• Design of Experiments (DOE)
• Failure Mode and Effects Analysis (FMEA)
• Statistical Process Control (SPC)
• Advanced Product Quality Planning (APQP)
• IQ/OQ/PQ validation protocols
• Lean Six Sigma / Kaizen
• Root‑cause analysis
• OEE monitoring and cost modeling

What we offer

• Cafeteria with fresh hot and cold food on‑site.
• Inclusive diversity programs and employee‑driven sustainability projects.
• Corporate events celebrating team successes.
• Strong focus on workplace safety and a stable work environment.