Packaging Engineer II

Responsibilities may include the following and other duties may be assigned:

You will be primary point of contact to collaborate with cross-functional teams, including Marketing, Product Development, Quality and Regulatory and supplier to define, develop, and finalize reusable packaging specifications in compliance with regulatory and quality requirements.

Design, develop, verify and validate reusable and single-use packaging solutions in line with regulatory and compliance standards.

Execute distribution simulation testing and perform fit checks to ensure packaging performance, proper configuration, and compliance with quality standards.

Develop packaging test protocols and prepare test reports; perform perforation assessments to verify sterilant penetration and document no-test rationale where applicable.

Execute cost-saving projects related to packaging design, materials and manufacturing methods. • Drive project management activities, leading technical and operational reviews to ensure alignment with timelines and milestones.

Required Knowledge and Experience:

Bachelor’s Bachelor’s or master’s degree in Packaging Engineering or Biomedical Engineering, Mechanical (or a related field) with 4-8 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.

Minitab experience with regression analysis, two-sample t-tests, and equivalence testing.

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 sterile reusable packaging systems and associated regulatory requirements including 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.

Familiarity with SAP process flows, including procurement, costing and material management workflows.

Familiarity with e-IFU processes and regulatory expectations for electronic labelling.

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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

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 [email protected].

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.