Medical Device Prototype / Clean Room Operator

Prunus Italy SRL, located in Mirandola, Italy is seeking a Medical Device Prototype / Clean Room Operator to contribute into the development of a new advanced medical device.

We are seeking a detail-oriented profile to join our dynamic Manufacturing and R&D team. This role is critical in supporting the prototyping and early-phase production of innovative medical devices within a clean room environment, ensuring compliance with stringent industry and regulatory standards.

Prunus Italy SRL is a subsidiary of Prunus Europe AG located in Switzerland. The position will report directly to the department leader.

Key Responsibilities:

• Assemble and fabricate early-stage medical device prototypes by design specifications and engineering instructions.
• Operate within ISO-classified clean room environments, adhering to proper gowning, hygiene, and contamination control protocols.
• Contribute to the prototype realization, from the raw material handling till the final assembly, also taking responsibility for the needed in-process inspections.
• Collaborate with engineers and quality personnel to refine and iterate prototypes.
• Assist in the setup, calibration, and maintenance of clean room equipment and workstations.
• Identify and report potential process improvements or quality issues proactively.

Qualifications:

• High school diploma or equivalent required; technical certification or associate degree preferred.
• Minimum 3 years of experience in a clean room or medical device manufacturing environment.
• Familiarity with clean room protocols (ISO 7 or ISO 8) and GMP/ISO 13485 standards.
• Strong attention to detail and manual dexterity, comfortable working with mechanical components and assembly.
• Operate with manufacturing and prototyping equipment under specific parameters and procedures.
• Ability to read and follow engineering drawings, schematics, and work instructions.
• Excellent communication skills and a team-oriented attitude.
• Basic computer proficiency (MS Office, data entry, etc.)
• Experience in the maintenance department will be considered as a plus

Company Profile

Prunus product portfolio grew through own development and acquisitions and includes today top-quality disposables and hardware for Critical Care.

Product portfolio ranges from central venous catheters, blood pressure monitoring systems, thermodilution catheters, embolectomy catheters, bipolar pacing catheters to highly innovative Ventilators and Anesthesia Machines which were developed in collaboration with the leading European partners. Today, the products are sold in over 70 countries, including the markets with high standards, such as Germany, Sweden, Switzerland, UK, Japan, USA, Singapore and other many others.

In order to strengthen the European footprint of the company and to develop and manufacture new products for the European markets, the group has established a new subsidiary in Italy and Switzerland.

The growing team based in Italy is dedicated to improving patient outcomes by delivering high-quality, safe, and effective Class IIb medical devices. We encourage growth, innovation, and collaboration in a supportive work environment.