Manufacturing Engineer - Packaging

Medartis Inc. - United States; Warsaw (IN); On-site; USD 85,000 - 105,000; Full time

Job summary

Medartis Inc. in Warsaw, Indiana seeks a Manufacturing Engineer to design, set up, validate, and operate a non-sterile packaging room in compliance with FDA QSR/21 CFR 820 and ISO 13485.

You will act as SME for current and future packaging operations, driving projects from concept through validated production. You will lead IQ/OQ/PQ validations, establish packaging processes, author procedures and BOMs, and collaborate across Quality, Operations, and Procurement to deliver robust, compliant

Qualifications

• Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Packaging, Biomedical) or related field.
• At least 5 years manufacturing engineering experience; minimum 3 years in medical devices.
• Experience setting up packaging room, cleanroom or controlled manufacturing areas.
• Experience with IQ/OQ/PQ validation protocols and project execution.
• Working knowledge of FDA QSR/21 CFR 820 and ISO 13485.

Responsibilities

• Lead the design, layout, and setup of a new non-sterile packaging room, including equipment selection and process flow.
• Develop, execute, and document cleaning validations for packaging area, equipment, and processes.
• Plan and execute non-sterile packaging projects for the U.S. market; support WW packaging projects as needed.
• Establish and qualify packaging processes and equipment (IQ/OQ/PQ) and support process validations.
• Author, maintain, and improve technical documentation such as work instructions, procedures, and routers.

Skills

Project management

Problem solving

Cross-functional collaboration

Regulatory understanding

Documentation

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ validation

MRP systems

Cleanroom setup

Job description

At Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world's leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.

The Manufacturing Engineer is responsible for the design, set-up, qualification, and ongoing operation of a non-sterile packaging room. This role leads the establishment of the packaging environment and its processes - including planning and executing cleaning validations and non-sterile packaging projects - and serves as the technical subject matter expert (SME) for current and future packaging operations. The position emphasizes hands-on problem solving to bring the packaging area from concept through validated, production-ready operation in compliance with applicable medical device regulations.

*This is an onsite position, located in Warsaw, IN*

Your Responsibilities

• Lead the design, layout, and set-up of a new non-sterile packaging room, including equipment selection, installation, and process flow.
• Develop, execute, and document cleaning validations for the packaging area, equipment, and associated processes.
• Plan and execute non-sterile packaging projects for the U.S. market; support worldwide (WW) packaging projects as applicable.
• Establish and qualify packaging processes and equipment (IQ/OQ/PQ) and support process validations.
• Author, maintain, and improve controlled technical documentation such as work instructions, procedures, protocols, reports, bills of materials, and routers in Medartis MRP systems.
• Troubleshoot and resolve a variety of complex product and process performance issues within the packaging operation.
• Drive continuous improvement activities to enhance quality, throughput, cost, and reliability of packaging processes.
• Participate in and/or lead on-the-job (OTJ) training of operators for packaging processes and equipment.
• Communicate (written and verbal) clear direction to the operations team relative to packaging processes.
• Support technical questions from operations, quality, and suppliers.
• Be able to represent Medartis as an SME during audits
• Coordinate tooling, material, and equipment needs with procurement and cross-functional partners.
• Ensure packaging operations comply with applicable regulatory and quality system requirements (e.g., FDA QSR / 21 CFR 820, ISO 13485).
• Travel: Some local/global traveling required to support projects when needed.

Your Qualifications

• Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Packaging, Biomedical) or a related technical field required.
• At least 5 years of manufacturing engineering experience required, with a minimum of 3 years in a medical device company.
• Demonstrated experience setting up and executing cleaning validations required.
• Demonstrated experience executing non-sterile packaging projects in the U.S. required; experience with worldwide (WW) packaging projects is a plus.
• Experience setting up a packaging room, cleanroom, or controlled manufacturing area is strongly preferred.
• Working knowledge of process and equipment validation (IQ/OQ/PQ) and validation protocol/report authoring required.
• Sound understanding of concepts and principles for manufacturing in new product processes required.
• Working knowledge in areas such as Quality, Operations, and New Product Introduction required.
• Knowledge of medical device regulations and standards (FDA QSR / 21 CFR 820, ISO 13485; ISO 11607 for packaging a plus) required.
• Strong problem-solving skills with the ability to analyze and resolve complex product and process issues.
• Ability to prioritize multiple complex project assignments and complete work in a timely manner.
• Ability to effectively work and communicate with any cross-functional team to complete critical project tasks.

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company.