Senior-level Packaging Engineer

Position Overview

A leading medical device company is seeking a Senior-level Packaging Engineer to support a major packaging integration program involving multiple workstreams and sites.

This is a hands-on Packaging Engineering role. The consultant will lead a packaging workstream while providing project management, facilitation, and cross-functional coordination as part of the engineering responsibilities.

The ideal candidate will have strong medical device packaging experience combined with expertise in design controls, packaging design verification and validation, ISO 11607, gap assessments, technical documentation, and workstream leadership .

Key Responsibilities

• Develop and execute packaging strategies and integration plans aligned with business and program objectives.
• Independently lead a packaging engineering workstream within a larger, complex program.
• Conduct packaging due diligence, assessments, and gap analyses across products, processes, materials, equipment, documentation, and quality systems.
• Identify packaging integration risks and gaps and develop appropriate mitigation and remediation plans.
• Perform complex packaging engineering activities involving packaging design, materials, processes, equipment, and component evaluation.
• Develop, review, and execute packaging verification and validation activities in accordance with applicable quality systems and regulatory requirements.
• Apply design control principles, including design inputs/outputs, risk assessment, verification, validation, and user-need alignment.
• Evaluate packaging systems against ISO 11607-1 and ISO 11607-2 requirements and support gap assessment activities.
• Develop and review technical documentation, including specifications, protocols, reports, DMR documentation, and process/test records.
• Manage packaging component activities, including component creation, documentation, sourcing, and supplier coordination.
• Design and coordinate engineering studies to investigate complex problems, analyze results, determine root cause, and develop sound technical recommendations.
• Collaborate with internal engineering, quality, operations, regulatory, supply chain, and other cross-functional teams.
• Work directly with suppliers and acquired sites to support packaging integration and implementation activities.
• Facilitate meetings, establish action items, manage milestones, and communicate workstream status, risks, and decisions to stakeholders.
• Provide technical guidance and mentorship to less-experienced engineers, technicians, or interns as applicable.

Required Qualifications

• Bachelor's degree in Packaging, Mechanical, Materials, Chemical, Industrial, Electromechanical, or related Engineering discipline.
• 5+ years of Packaging Engineering experience; 8-15 years of relevant experience is preferred.
• Strong experience in medical device packaging.
• Demonstrated experience with packaging design, development, manufacturing, or integration.
• Strong understanding of design controls and regulated product development, including design inputs/outputs, risk assessment, verification, validation, and process validation.
• Hands-on experience with packaging verification and validation.
• Working knowledge of ISO 11607-1 and ISO 11607-2.
• Experience performing packaging gap assessments.
• Strong technical writing and documentation skills, including specifications, protocols, reports, and quality-system documentation.
• Demonstrated ability to independently manage complex engineering activities and drive work to completion.
• Strong project management, facilitation, organization, and cross-functional communication skills.
• Ability to travel as needed to support suppliers and other company locations.

Preferred Qualifications

• Experience supporting mergers, acquisitions, or site/product integrations.
• Experience developing packaging integration strategies across multiple sites or business units.
• Experience with sterile barrier systems and medical device packaging.
• Familiarity with packaging materials including Tyvek, flexible films, thermoformed trays, corrugated, paperboard, and injection-molded components.
• Experience with ASTM and ISTA packaging test methods.
• Familiarity with packaging-related PLM, MES, ERP, or manufacturing systems.
• Experience working directly with suppliers on packaging development, qualification, or transfer.
• Consulting experience or demonstrated ability to quickly enter a new organization and independently drive complex workstreams.