Packaging Engineer II

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.

Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life As a Packaging Engineer at MEIC, you will partner with Marketing, Regulatory and cross-functional teams to deliver reusable and single-use packaging solutions with a primary focus on reusable systems (Mesh baskets, Metal trays, etc) and your responsibilities include developing instrument layout configurations aligned with packaging and usability requirements, managing supplier collaboration, coordinating cleaning and validation activities, owning project timelines and deliverables, supporting DHF submissions, and supporting EU‑MDR remediation initiatives to ensure compliance with regulatory, quality and GMP standard.

Responsibilities may include the following and other duties may be assigned: You will collaborate with cross-functional teams, including Marketing, Product Development, Quality, and Regulatory to define, develop, and finalize reusable packaging specifications in compliance with regulatory and quality requirements.

Design and develop reusable packaging (Metal trays, Mesh baskets, Inner trays and Lids) solutions by establishing instrument layout configurations aligned with packaging, usability, cleaning and sterilization requirements. Execute distribution simulation testing and perform fit checks to ensure packaging performance, proper configuration, and compliance with quality standards.

Coordinate with suppliers to support development, validation and readiness of reusable packaging solutions, ensuring alignment with project timelines and deliverables. Develop packaging test protocols and prepare test reports; perform perforation assessments to verify sterilant penetration and document no-test rationale where applicable.

Packaging costing experience, including cost analysis and optimization. Identify and execute cost-saving initiatives related to packaging design, materials, and processes while maintaining compliance with quality and regulatory standards. Drive project management activities, including planning, tracking, coordinating cross-functional deliverables, leading reviews and ensuring alignment with timelines and milestones.

Serve as the primary point of contact across internal teams and suppliers, facilitating communication, resolving risks/issues, and ensuring smooth execution and decision-making. Engage and collaborate with multiple suppliers to develop and implement packaging solutions, ensuring compliance with quality standards and project timelines.

Required Knowledge and Experience : Bachelor’s or master’s degree in Packaging Engineering or Biomedical Engineering, Mechanical (or a related field) with 4 to 8 years of relevant experience in design and develop reusable packaging. Experience on managing at least two end-to-end packaging projects from concept through validation and implementation.

Proficiency in Microsoft Project or equivalent project management tools. Experience working with Agile PLM systems for managing product lifecycle data, documentation, ECOs, and change processes. Strong working knowledge of ASTM standards in alignment with ISO 11607‑1 and ISO 11607‑2 for packaging validation and compliance.

Hands-on experience in performing runout testing and other relevant validation activities to ensure packaging and instrument performance meets quality requirements. Experience in identifying and implementing cost optimization opportunities in packaging design while maintaining compliance.

Hands-on experience in sterile reusable packaging systems and associated regulatory requirements. Strong understanding of ISO 15883 (cleaning validation) and ISO 17665 (steam sterilization). Experience with labeling requirements per ISO 15223, good to have.

Hands-on experience with EU-MDR compliance, including Technical File remediation and gap assessments. Proficiency in CREO or SOLIDWORKS for design and development support. Experience in sterile packaging systems (Rigid/Flexible). Familiarity with SAP process flows, including procurement, costing and material management workflows.

Ability to identify and implement cost optimization initiatives in packaging design and processes. Familiarity with e‑IFU processes and regulatory expectations for electronic labelling. Experience with EU‑MDR remediation activities, including Technical File updates, gap assessments, and compliance alignment.

Experience with sustainability initiatives, including material reduction, recyclability, and environmental compliance. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com . Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values.

We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).