Manufacturing Engineer

Prunus Italy Srl, a subsidiary of Prunus Europe AG headquartered in Switzerland, is seeking a highly qualified Manufacturing Engineer to lead the setup and optimization of manufacturing processes for disposable medical devices at its newly established cleanroom facility in Mirandola, Italy.

The selected candidate will play a key role in establishing production capabilities from the ground up, ensuring regulatory compliance, manufacturing efficiency, and product quality in line with international standards. This position reports directly to the Chief Technology Officer (CTO) of Prunus Italy.

Company Overview

Prunus develops and markets a comprehensive portfolio of high-quality disposables and capital equipment for Critical Care and Anesthesia. The product range includes central venous catheters, blood pressure monitoring systems, thermodilution and embolectomy catheters, bipolar pacing catheters, as well as advanced ventilators and anesthesia machines developed in partnership with leading European institutions.

Prunus products are sold in over 70 countries, including highly regulated markets such as Germany, Sweden, Switzerland, the UK, Japan, the USA, and Singapore. To further strengthen its presence in Europe and support the development of innovative devices for the European market, the group has established new subsidiaries in Switzerland and Italy.

The growing Italian team is committed to improving patient outcomes through the development and manufacturing of high-quality, safe, and effective Class IIb medical devices, within a collaborative and innovation-driven environment.

Key Responsibilities

• Develop, validate, and optimize manufacturing processes for disposable medical devices, including extrusion, injection molding, assembly, bonding, and sterile packaging.
• Lead and document process validation activities (IQ, OQ, PQ) in compliance with ISO 13485 and FDA requirements.
• Collaborate closely with R&D, Quality, and Regulatory Affairs to ensure successful design transfer and manufacturability of new products.
• Ensure the availability and maintenance of accurate technical documentation, including SOPs, process flows, work instructions, and Device History Records (DHR).
• Oversee cleanroom manufacturing activities and ensure strict compliance with GMP, sterility assurance, and packaging integrity standards.
• Identify, evaluate, and manage external suppliers for the procurement and installation of advanced production equipment.
• Define and optimize key process parameters using Lean Manufacturing and Six Sigma methodologies.
• Train and support production personnel on new equipment, process controls, and quality inspection techniques.
• Ensure reliable operation and preventive maintenance of manufacturing equipment by developing appropriate maintenance procedures.

Qualifications

• Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• Minimum 5 years of experience in a manufacturing engineering role within the medical device industry, preferably involving disposable Class II products.
• In-depth knowledge of regulatory and quality standards: ISO 13485, ISO 14971, FDA and GMP.
• Demonstrated experience in process validation, equipment qualification, and statistical data analysis.
• Familiarity with cleanroom environments and sterile packaging techniques.
• Excellent analytical, organizational, and cross-functional communication skills.
• Proficiency in written and spoken English.
• Working knowledge of CAD tools and automation technologies is considered a plus.

Preferred Certifications

• Six Sigma Green Belt or higher
• Lean Manufacturing certification
• Proficiency with statistical analysis tools (e.g., Minitab)

This is an outstanding opportunity for a technically skilled and regulatory-savvy professional to contribute to the creation of a new state-of-the-art production facility and to play a pivotal role in shaping the future of an ambitious and growing international MedTech company.