Manufacturing Engineer - Medical Devices

Join our dynamic Manufacturing & Supply Chain team and play a key role in developing, optimizing, and sustaining world-class manufacturing processes for life-changing medical devices.

Requirements

• Lead the design, development, and optimization of manufacturing processes for Class I, II, and III medical devices.
• Ensure full compliance with ISO 13485, MDSAP, FDA QSR, GMP, and other relevant regulatory standards.
• Work closely with R&D, Quality, Regulatory, and Operations to ensure new products are manufacturable, scalable, and cost-effective.
• Develop and execute process validation protocols (IQ/OQ/PQ) and support risk management activities such as PFMEA.
• Design fixtures, tooling, and production layouts using AutoCAD, SolidWorks, and other CAD tools.
• Drive Lean, Six Sigma, and SPC initiatives to improve process capability, efficiency, and yield.
• Use data analytics to monitor performance, identify trends, and drive decisions using tools such as Excel, Minitab, Python, or Power BI.
• Investigate and resolve manufacturing issues through structured root cause analysis and corrective actions.
• Support cleanroom operations and ensure adherence to environmental and GMP requirements.
• Lead capital equipment selection, installation, qualification, and performance verification.
• Build business cases to support process improvements and capital investments.
• Plan and manage engineering project budgets, timelines, and deliverables.
• Mentor junior engineers and provide guidance to cross-functional teams.
• Support internal and external audits and maintain readiness for MDSAP criteria.

Benefits

• Competitive salary
• Benefits package
• Opportunities for professional growth and development