BD

Staff Packaging Engineer

BD

full-time

Posted on:

Location Type: Hybrid

Location: Warwick • Illinois • Rhode Island • United States

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Salary

💰 $113,400 - $186,900 per year

Job Level

Lead

About the role

  • Lead packaging engineering activities for new products, line extensions, and sustaining programs, ensuring alignment with project timelines, cost, quality, and regulatory requirements
  • Provide technical leadership in packaging concept development, material selection, design inputs, and validation strategies
  • Serve as a key technical contributor and subject‑matter expert for packaging technologies, materials, methods, and processes within cross‑functional project teams
  • Drive packaging deliverables through all phases of the product lifecycle, from concept through commercialization and sustaining support
  • Design and develop primary, secondary, and tertiary packaging solutions for sterile and non‑sterile medical devices
  • Lead packaging feasibility studies, risk assessments, and design‑for‑manufacturability evaluations
  • Develop prototype packaging, and coordinate tooling and equipment needs to support development and testing
  • Manage packaging‑related changes for sustaining products, including component, supplier, and process changes
  • Prepare packaging cost estimates as required
  • Develop and execute packaging test plans, including transit testing, shelf‑life studies, environmental conditioning, and performance evaluations
  • Lead qualification and validation of packaging components, equipment, processes, and operations in compliance with FDA, ISO, ASTM, ICH, and USP requirements
  • Analyze test data and independently author technical reports, validation summaries, and documentation to support regulatory submissions, product launches, and design changes
  • Troubleshoot packaging performance and manufacturing issues using structured problem‑solving methodologies and corrective action approaches
  • Plan and coordinate all packaging engineering activities to support product launch and transfer to manufacturing, including development and execution of packaging transfer plans
  • Coordinate packaging documentation release, test protocols, reports, and design control documentation
  • Support planning, ordering, and coordination of new packaging component inventory to meet launch and production needs
  • Collaborate closely with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Labeling, Marketing, and external partners to ensure packaging solutions meet all functional requirements
  • Work with suppliers, vendors, and contract manufacturers to develop, optimize, qualify, and maintain packaging components and materials
  • Provide technical support for internal and external audits, inspections, and design reviews related to packaging
  • Identify and implement packaging improvements that enhance product performance, manufacturability, cost efficiency, and sustainability
  • Support cost‑reduction and manufacturing improvement initiatives related to packaging
  • Stay current with evolving industry standards, regulations, materials, and technologies impacting packaging

Requirements

  • B.S. degree in Packaging Engineering/Packaging Science, Life Sciences, or related Engineering discipline, with 8+ years of relevant packaging engineering experience
  • 5 years of experience in the medical device industry
  • 3 years of experience with sterile medical device packaging specifically
  • Solid experience in packaging design, materials, testing, validation, and commercialization
  • Working knowledge of FDA requirements and functional needs for sterile medical devices
  • Broad knowledge of properties of primary and secondary packaging materials, packaging methods, equipment, and processes
  • Working knowledge of package test methods, process validation, barcoding, and international standards
  • Strong written and verbal communication skills, including ability to independently author and analyze technical documentation
  • Proven ability to manage multiple concurrent assignments and drive projects to completion on time and within budget
  • Demonstrated ability to influence cross-functional teams and guide execution without direct authority
Benefits
  • Competitive salary
  • Health insurance
  • Retirement plans
  • Paid time off
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
packaging engineeringpackaging designmaterial selectionvalidation strategiespackaging testingrisk assessmentsdesign-for-manufacturabilityprototype developmentpackaging cost estimationpackaging lifecycle management
Soft Skills
technical leadershipcommunication skillsproject managementcross-functional collaborationproblem-solvinginfluencing skillstime managementanalytical skillsdocumentation authoringbudget management