Packaging Engineer – Non-sterile Medical Devices (Onsite)

Medartis AG; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Medartis AG in the United States is seeking a Manufacturing Engineer to design, set up, and validate a non-sterile packaging room for the U.S. market. You will lead the packaging environment establishment and drive continuous improvement in quality, throughput, and cost.

The role requires hands-on problem solving, compliance with FDA QSR / 21 CFR 820, and ISO 13485, with travel as needed to support projects worldwide. A related engineering degree and medical device experience are essential.

Qualifications

• Bachelor's degree in engineering is required (Mechanical, Manufacturing, Industrial, Packaging, Biomedical).
• At least 5 years of manufacturing engineering experience in a medical device environment.
• Experience setting up a packaging room and executing cleaning validations required.

Responsibilities

• Lead design, layout, and setup of a new non-sterile packaging room with equipment selection and process flow.
• Develop, execute, and document cleaning validations for packaging area and equipment.
• Plan packaging projects for the U.S. market; support worldwide packaging projects as applicable.
• Qualify packaging processes and equipment (IQ/OQ/PQ) and support process validations.
• Create and maintain controlled technical documentation and SOPs for packaging.

Skills

Packaging engineering

Regulatory knowledge

Cross-functional collaboration

Problem solving

Cleaning validations

Education

Bachelor's degree in engineering

Tools

Medartis MRP systems

Job description

Medartis AG in the United States is seeking a Manufacturing Engineer to design, set up, and validate a non-sterile packaging room for the U.S. market. You will lead the packaging environment establishment and drive continuous improvement in quality, throughput, and cost.

The role requires hands-on problem solving, compliance with FDA QSR / 21 CFR 820, and ISO 13485, with travel as needed to support projects worldwide. A related engineering degree and medical device experience are essential.