Packaging Engineer

Responsibilities

• Packaging & Manufacturing Engineering:
  • Design and develop primary, secondary, and tertiary packaging systems for medical devices.
  • Select and qualify packaging materials (pouches, blisters, trays, cartons, labels).
  • Support packaging line setup, equipment qualification, and process optimization.
  • Develop and maintain manufacturing processes aligned with product and packaging requirements.
  • Drive cost reduction and efficiency improvements without compromising quality or compliance.
• Validation & Regulatory Compliance:
  • Lead and/or support packaging and manufacturing validations, including IQ / OQ / PQ.
  • Package integrity testing (seal strength, bubble leak, dye penetration).
  • Distribution simulation and shelf life (aging) studies.
  • Ensure compliance with ISO 11607, FDA 21 CFR 820/QSR, ISO 13485, and applicable ASTM and internal standards.
  • Author and review validation protocols, reports, and technical documentation.

Qualifications

• Bachelor's degree in Engineering (preferred: Packaging, Biomedical Engineering, or related field).
• Minimum 5 years of relevant experience in medical device packaging and manufacturing.
• Experience with ISO 11607, FDA 21 CFR 820/QSR, and ISO 13485.
• Strong knowledge of packaging materials, manufacturing processes, and regulatory requirements.
• Excellent problem-solving skills and ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite and familiarity with industry-standard software tools.

Skills

• Packaging and manufacturing engineering principles.
• Regulatory compliance and quality assurance.
• Cost analysis and process improvement techniques.
• Project management and leadership skills.
• Technical writing and documentation.

Benefits

• Competitive salary commensurate with experience.
• Flexible working hours and remote work options.
• Professional development opportunities and training programs.
• Health insurance and retirement benefits.

Schedule

• Full-time position.
• Standard Monday through Friday workweek.

Pay

• $XX.XX - $XX.XX per hour based on experience.