Lead the packaging engineering lab responsible for qualifying medical device packaging
Oversee daily lab operations including test scheduling, equipment maintenance, inventory control, and compliance with Standard Test Procedures (STPs) and Good Documentation Practices (GDP)
Manage multiple direct reports; provide technical and team leadership for packaging lab technicians
Collaborate with cross-functional teams in new product development, on-market improvements, and distribution packaging qualifications
Perform hands-on testing as needed, maintain accurate records, and report lab performance metrics
Drive continuous improvement and ensure alignment with quality and regulatory standards
Design new or update existing secondary and/or tertiary packaging for diagnostic products
Schedule and track packaging tests to ensure timely execution and on-time release of test reports
Oversee equipment calibration and qualification activities (IQ, OQ, PQ) and dangerous goods certification program
Maintain lab equipment and facilities in functional and clean condition
Lead risk assessments and implement mitigation strategies to ensure packaging integrity and regulatory compliance
Provide packaging technical support and expert services to manufacturing sites and divisions
Generate cost savings ideas, complete proof of concept development, and deliver annual cost savings
Serve as Subject Matter Expert (SME) during internal and external audits
Improve sustainability for on-market packaging products
Drive capital planning and investment strategies for lab infrastructure, including equipment upgrades and technology adoption
Requirements
Bachelors Degree in engineering, physical sciences, mathematics, or closely related field
6 years of progressive responsible experience
Higher education can substitute for work experience
Strong understanding of primary, secondary, and tertiary packaging materials and their qualification for healthcare products
Experience in packaging, R&D, or operations within the medical device or regulated industry
Skilled in managing lab workflows, equipment, inventory, and testing schedules
Proven ability to independently lead lab projects, manage budgets, and allocate resources effectively
Familiar with FDA, DOT, IATA, ASTM, ISTA, GMP, and GDP standards
Experience with 1D/2D barcodes and labeling
Experienced in developing Standard Test Procedures/OPs and serving as SME during audits
Capable of mentoring lab staff and working cross-functionally with engineering, QA, and manufacturing teams
Dangerous Goods Certification preferred
Good knowledge of ISO, ASTM, ISTA standards
Good understanding of statistics including DoE, sample size calculations, statistical process controls
Knowledge of lean six sigma methodologies
Experience with Artios CAD
Benefits
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit (affordable path to a bachelor’s degree)
Health and wellness benefits
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
packaging engineeringtest schedulingequipment maintenanceinventory controlpackaging materials qualificationStandard Test ProceduresGood Documentation Practicesrisk assessmentslean six sigmastatistical process controls