Senior Packaging Engineer - North Haven

Senior Packaging Engineer

Join Medtronic's North Haven manufacturing team as a Senior Packaging Engineer, where you'll play a critical role in supporting the production of innovative medical technologies that improve patient lives around the world. This highly visible position combines hands-on manufacturing support, process development, equipment validation, and continuous improvement initiatives within a fast-paced, highly regulated environment. You'll work closely with cross-functional partners to ensure packaging processes are efficient, compliant, and capable of delivering the highest levels of quality and performance.

In this role, you'll serve as both a technical leader and collaborative problem solver, partnering with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to drive process improvements, troubleshoot manufacturing challenges, lead equipment and packaging validations, and support long-term projects that enhance product quality and operational performance. The ideal candidate is proactive, adaptable, and comfortable taking ownership while working across a large manufacturing organization to deliver results that directly impact patients and business outcomes.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

• Provide input to solve complex problems including, but not limited to, those related to process, equipment, documentation, equipment validation, Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ).
• Lead and coordinate activities of engineers and technicians in support of process and equipment development, testing, process trouble shooting, and custom equipment procurement.
• Prepare, review, and approve manufacturing instruction, protocols, reports, and other controlled documentation.
• Lead and participate in documented vs. actual gap analysis activities.
• Participate in resolution of Non-Conformances and Corrective and Preventive Actions (CAPA)
• Coordinate with other departments to understand automation, assembly, packaging, process engineering, quality, regulatory, effectiveness, and timeliness of the product/process and production flow process and make sure the manufactured product is following regulatory quality standards.
• Provide supervision and mentorship to engineers, technicians, and other tier employees.
• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Assess process steps and perform failure analysis for assembly/manufacturing process.
• Adapts machine or product design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.
• Lead the project team through development of plans and roadmaps for project execution.
• Interface with senior management and cross functional team to assign deliverables and communicate / report progress. Receive strategic updates impacting the projects.
• Develop timelines and milestones for project deliverables.
• Closely monitor progress vs. plan and take action as required to keep project on track.

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline with 4+ years of relevant experience
• OR Master's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline with 2+ years of relevant experience
• OR PhD in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline with 0 years of relevant experience

• Experience supporting packaging operations within a regulated industry such as medical device, pharmaceutical, biotechnology, or aerospace manufacturing
• Hands-on experience with packaging equipment, sealing technologies, and packaging process validation activities (IQ/OQ/PQ)
• Knowledge of manufacturing quality systems, non-conformance investigations, CAPA, and risk…