Packaging DHF Compliance Engineer

Lancesoft; Warsaw (IN); On-site; USD 55,000 - 96,000; Part time

Job summary

Lancesoft is seeking a Packaging Engineer to support DHF remediation and EOL activities. The role focuses on establishing baseline DHF packaging content and identifying regulatory gaps to meet client requirements.

Responsibilities include reviewing DHF docs, identifying standards (ISO 13485, ISO 11607-1/2, 21 CFR 820, EU MDR), and coordinating with quality, regulatory, and project stakeholders to confirm expectations. 1 year minimum packaging-related experience is required.

Qualifications

• Must have relevant experience with DHF for packaging
• Experience aligning packaging with ISO 13485, ISO 11607, 21 CFR 820
• Ability to identify gaps and coordinate remediation activities

Responsibilities

• Review DHF documentation related to packaging design, materials, testing, labeling, and validation
• Identify applicable standards and regulations (ISO 13485, ISO 11607-1/2, 21 CFR 820, EU MDR)
• Assess completeness and compliance of packaging documentation within the DHF
• Identify gaps related to packaging design inputs/outputs, validation, aging, labeling
• Coordinate with quality, regulatory, and project stakeholders to confirm expectations

Skills

DHF assessment report

Packaging gap analysis

Regulatory & standards alignment

Packaging remediation plan

Education

Bachelor's degree + 1 year exp

Associate's degree + 3 years exp

High School diploma + 5 years exp

Job description

Lancesoft is seeking a Packaging Engineer to support DHF remediation and EOL activities. The role focuses on establishing baseline DHF packaging content and identifying regulatory gaps to meet client requirements.

Responsibilities include reviewing DHF docs, identifying standards (ISO 13485, ISO 11607-1/2, 21 CFR 820, EU MDR), and coordinating with quality, regulatory, and project stakeholders to confirm expectations. 1 year minimum packaging-related experience is required.