Packaging Engineer

Location:

Franklin Lakes, NJ (Onsite 4 days/week, Remote Friday)

Contract:

12 months | Pay: $50-56.49/hr

About the Role:

We are seeking a hands-on Packaging Design Engineer with strong medical device experience to lead packaging design change projects. You will coordinate across stakeholders, manage projects, and ensure regulatory compliance for device packaging such as syringes and needles.

Key Responsibilities:

• Lead packaging design change projects from concept through execution.
• Drive cross-functional projects involving internal teams and third-party vendors.
• Ensure design controls compliance and execute documentation and registration activities.
• Support regulatory activities for packaging, including labeling, registration, and testing.
• Develop and execute test methods, including aging studies, shipping/distribution tests, and risk assessments.
• Maintain project documentation in SAP and follow quality policies.
• Utilize tools like Minitab and other statistical methods to analyze and report results.
• Contribute to innovation and process improvements for current and future packaging solutions.

Must-Have

Qualifications:

• BS/BA in Engineering (Mechanical or Biomedical preferred).
• 4+ years of packaging engineering experience in medical devices.
• Experience with packaging design changes and medical device regulatory environment.
• Strong understanding of Design Controls, device registration, and documentation requirements.
• Project management experience—able to coordinate stakeholders and drive execution.
• Experience with 3rd party vendors and cross-functional teams.
• Familiarity with testing, shipping, distribution testing, aging studies, and risk assessments.
• Experience with SAP and documentation control.
• Hands-on, proactive, and able to generate technical reports and recommendations.

Nice-to-Have:

• Experience at medical device companies or exposure to similar regulatory environments.
• Statistical analysis experience (Minitab).
• Onsite 4 days/week, remote Fridays.
• Fast-paced, collaborative, and project-focused team.