Staff Engineer, Packaging - Wayne, NJ

Job Overview

This position serves as a technical leader and subject matter expert for packaging systems, labeling, and sterile barrier solutions supporting Cardiac Surgery and Vascular Intervention product portfolios. This role drives the development, validation, commercialization, lifecycle management, and continuous improvement of complex packaging systems while ensuring compliance with global regulatory requirements.

The Staff Packaging Engineer provides strategic technical leadership across multiple programs, mentors engineers, influences packaging standards and best practices, partners with cross-functional stakeholders, and leads initiatives that improve product quality, patient safety, manufacturing efficiency, supply continuity, and total cost of ownership.

Technical Leadership

• Serve as the packaging engineering subject matter expert (SME) for sterile and non-sterile medical device packaging systems.
• Lead packaging strategy, design, development, validation, and commercialization activities for new product development and sustaining engineering projects.
• Establish technical direction for packaging technologies, materials, validation methodologies, and packaging standards.
• Drive innovation and continuous improvement initiatives focused on quality, reliability, sustainability, manufacturability, and cost optimization.
• Mentor and provide technical guidance to packaging engineers and cross-functional project teams.

Packaging Development

• Lead the design and development of sterile barrier systems and protective packaging solutions in compliance with ISO 11607 and applicable global regulations.
• Evaluate and select packaging materials based on product requirements, sterilization compatibility, transportation risks, shelf-life requirements, and environmental considerations.
• Guide packaging architecture decisions across product platforms and manufacturing sites.
• Lead packaging component specifications, drawings, and technical documentation development.
• Support platform standardization and harmonization initiatives across the portfolio.

Validation and Compliance

• Develop and approve validation strategies and protocols including: IQ, OQ, PQ, Process validation, Packaging validation, Package integrity testing, Transportation simulation testing, Accelerated and real-time aging studies, and Labeling system validation.
• Lead risk assessments utilizing Design Failure Mode and Effects Analysis (DFMEA), Process FMEA, and hazard analysis methodologies.
• Ensure compliance with ISO 11607, ISO 13485, FDA 21 CFR Part 820, EU MDR, UDI requirements and Global medical device regulations.

Manufacturing and Operations Support

• Partner with Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Operations teams to implement robust packaging solutions.
• Lead resolution of packaging-related manufacturing issues and non-conformances.
• Support investigations, CAPAs, complaint trending, and quality system activities.
• Drive process capability improvements through statistical analysis and data-driven decision-making.
• Lead supplier qualification activities and packaging component change management.

Strategic and Business Impact

• Lead cross-functional projects with significant business, technical, and regulatory complexity.
• Identify and execute cost reduction opportunities through packaging redesign, material optimization, and supplier management.
• Support business continuity initiatives related to packaging materials and suppliers.
• Influence organizational packaging standards, engineering practices, and technology roadmaps.
• Present technical recommendations and project updates to senior leadership.

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, or related technical discipline. Master’s degree in Engineering, Packaging Engineering, or related discipline (preferred).
• Minimum 8+ years of progressively responsible packaging engineering experience, preferably within the medical device, pharmaceutical, or regulated healthcare industry.
• Demonstrated experience leading complex packaging development and validation programs from concept…