PACKAGING ENGINEER
Job Summary
The Staff Packaging Engineer serves as the technical lead for packaging design, development, verification, validation, implementation, and lifecycle management activities supporting MMS Dispensing products. This role develops robust packaging systems that protect complex electromechanical medical devices, subassemblies, accessories, service parts, and field retrofit kits throughout handling, storage, distribution, installation, and service.
The position partners with R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain, Procurement, Service, Marketing, and external suppliers. The Staff Packaging Engineer provides technical leadership for new product development, sustaining engineering, remediation programs, manufacturing transfers, supplier changes, global product releases, cost improvement, and packaging sustainability initiatives.
Job Responsibilities
Technical Leadership
· Lead packaging engineering activities for new product development, sustaining engineering, remediation programs, and design changes across the MMS Dispensing portfolio.
· Serve as the packaging subject matter expert on cross-functional project teams and design reviews.
· Develop packaging strategies, technical plans, schedules, resource estimates, and deliverables for complex programs.
· Provide technical direction and mentoring to engineers, technicians, suppliers, and project team members.
· Lead complex investigations related to packaging performance, transportation damage, field complaints, installation concerns, and supplier quality issues.
Packaging Design and Development
· Design and develop primary, secondary, and tertiary packaging for dispensing hardware, modules, peripherals, accessories, spare parts, and field retrofit kits.
· Translate product, customer, regulatory, quality, manufacturing, service, and distribution requirements into documented packaging requirements and design solutions.
· Create packaging concepts, prototypes, engineering drawings, specifications, bills of material, and acceptance criteria.
· Evaluate and select materials, cushioning systems, corrugated structures, pallets, crates, protective films, labels, and related components.
· Apply design-for-manufacturing, design-for-assembly, serviceability, ergonomics, sustainability, and total-cost considerations.
· Ensure package designs support safe handling, storage, shipment, unpacking, installation, and disposal across global distribution environments.
Testing and Validation
· Develop risk-based packaging verification and validation strategies aligned with product and distribution requirements.
· Author and approve engineering studies, test protocols, reports, technical assessments, and design verification documentation.
· Plan and execute vibration, shock, drop, compression, environmental conditioning, handling, and distribution simulation testing.
· Define representative test samples, acceptance criteria, test configurations, and rationale for test methods.
· Analyze test results, document conclusions, resolve failures, and establish objective evidence that requirements have been met.
· Coordinate testing with internal laboratories, external laboratories, manufacturing sites, and suppliers.
Quality, Regulatory, and Design Control Compliance
· Ensure packaging activities comply with applicable quality system procedures, design controls, risk management requirements, and document control practices.
· Contribute to design inputs, design outputs, design reviews, verification, validation, design transfer, and change control deliverables.
· Support packaging-related risk analyses, including design and process failure mode evaluations and hazard assessments.
· Provide packaging content for regulatory submissions, technical documentation, audit responses, and remediation records as required.
· Maintain clear traceability among packaging requirements, risks, specifications, test methods, results, and released design artifacts.
Supplier and Manufacturing Support
· Partner with suppliers to develop, prototype, source, qualify, and implement packaging materials and systems.
· Lead supplier technical reviews and support supplier selection, qualification, change assessment, and issue resolution.
· Collaborate with Manufacturing Engineering and Operations to define packaging processes, equipment, work instructions, inspection methods, and process controls.
· Support commercialization, manufacturing transfers, pilot builds, production readiness, and global deployment activities.
· Provide technical support for nonconformances, corrective actions, deviations, and packaging process improvements.
Sustaining Engineering and Lifecycle Management
· Lead packaging changes associated with product updates, component obsolescence, supplier changes, manufacturing transfers, remediation, and regulatory needs.
· Investigate packaging-related field issues and transportation damage using structured root cause analysis and data-driven problem solving.
· Identify and implement opportunities for packaging standardization, simplification, sustainability, quality improvement, and cost reduction.
· Maintain packaging specifications, drawings, bills of material, test methods, and design history documentation throughout the product lifecycle.
· Monitor packaging performance and recommend preventive or corrective actions based on complaint, quality, supplier, manufacturing, and distribution data.
Education
Required
· Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.
Preferred
· Master's degree in Packaging Engineering, Engineering, or a related technical discipline.
Experience
Required
· Minimum of 5-7 years of packaging engineering or closely related product development experience.
· Demonstrated experience leading packaging design, development, verification, validation, implementation, and lifecycle activities.
· Experience leading cross-functional technical projects and resolving complex engineering problems.
· Experience developing packaging for complex products, equipment, hardware systems, or regulated products.
Preferred
· Experience in the medical device, pharmaceutical, diagnostics, or other regulated industry.
· Experience supporting electromechanical medical devices, capital equipment, dispensing systems, or healthcare hardware.
· Experience with transportation and distribution testing, package qualification, and environmental conditioning.
· Experience supporting global product launches, sustaining engineering, remediation programs, manufacturing transfers, and supplier management.
· Experience with service-part, accessory, or field-retrofit-kit packaging.
Knowledge, Skills, and Abilities
· Strong knowledge of packaging engineering principles, protective packaging methods, packaging materials, and distribution environments.
· Working knowledge of recognized package testing practices and relevant ASTM and ISTA test methods.
· Knowledge of medical device design controls, risk management, verification and validation, change control, and quality system requirements.
· Ability to create and review packaging drawings, specifications, bills of material, test protocols, reports, and technical assessments.
· Experience with packaging design or CAD tools such as ArtiosCAD, AutoCAD, or SolidWorks.
· Proficiency in statistical analysis, test planning, root cause analysis, tolerance assessment, and data-driven decision making.
· Strong project leadership, organization, written communication, and stakeholder management skills.
· Ability to influence decisions, manage competing priorities, and work effectively across global and cross-functional teams.
· Ability to communicate technical information clearly to engineering, quality, regulatory, operations, service, suppliers, and leadership.
