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Senior Packaging Development Engineer
Integra LifeSciences. Lead the planning, design, development, and improvement of package systems for sterile and non-sterile medical devices .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in packaging systems for medical devices, ensuring compliance with regulatory standards and quality requirements. Proficient in statistical analysis, design of experiments, and technical documentation to support packaging initiatives and process validation.
Highest-signal resume keywords
Quality System Regulation (QSR)Design ControlsProcess ValidationDesign of Experiments (DOE)Statistical Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Packaging MaterialsRisk ManagementValidation PrinciplesTechnical WritingEngineering Drawings InterpretationGMPANOVACapability AnalysisISO 11607ISO 13485
Soft Skills
Effective CommunicationCollaborationProject Management
Tools & Technologies
Microsoft OfficeStatistical Tools
Industry Keywords
FDA RequirementsISO 14971ASTM StandardsISTA Requirements
About the role
Key responsibilities & impact- Lead the planning, design, development, and improvement of package systems for sterile and non-sterile medical devices
- Ensure medical device packaging meets requirements for functionality, safety, manufacturability, regulatory compliance, sustainability, and business objectives
- Define and refine design requirements, performance criteria, and business needs through cross-functional collaboration
- Collaborate with R&D, Quality, Regulatory, Labeling, Operations, and suppliers across the product lifecycle
- Lead or contribute to packaging initiatives focused on best practices, quality improvements, cost effectiveness, and standard work
- Apply packaging materials, processes, test methods, design controls, risk management, and validation principles
- Execute assigned project tasks, including documentation, coordination, and defined methodologies
- Develop and evaluate packaging concepts using internal and external resources
- Plan and execute Design of Experiments (DOE), including setup, data collection, and documentation
- Apply statistical methods and engineering judgment to analyze data and support decisions
- Support packaging-related process validation, including OQ and PQ execution
- Analyze data, identify trends and root causes, and develop conclusions and recommendations
- Prepare and review technical reports, protocols, and documentation
- Provide guidance to junior engineers and may lead small project teams or workstreams
- Report directly to the Manager of Packaging Engineering
Requirements
What you’ll need- Bachelor degree with 5+ years of experience or equivalent education and years of experience
- Master degree with 3+ years of experience or equivalent education and years of experience
- Doctoral degree with 0-2 years of experience or equivalent education and years of experience
- Strong knowledge of Quality System Regulation (QSR), GMP, Design Controls, and basic Process Validation principles within the medical device industry
- Familiarity with FDA, ISO, ASTM, and ISTA requirements for packaging and labeling
- Ability to apply ISO 11607 (Parts 1 and 2), ISO 13485, ISO 14971, and FDA 21 CFR Part 820
- Solid understanding of packaging materials, structures, components, and related conversion processes
- Ability to read and interpret engineering drawings, with exposure to GD&T methodologies
- Ability to manage multiple assigned tasks and priorities with direction
- Strong working knowledge and application of DOE, ANOVA, capability analysis, histograms, and normality testing
- Strong technical writing and documentation skills
- Effective written and verbal communication skills
- Fully versed in Microsoft Office software and tools, including Outlook, Project, PowerPoint, Word, and Excel
- Use of statistical tools
- Ability to repeatedly sit, listen, and speak; periodically lift and/or move up to 20 lbs
- Formal application, oral interview, reference check, and potentially job-related tests
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short- and long-term disability
- Business accident insurance
- Group legal insurance
- Savings plan (401(k))