Packaging Engineer - Must Have Medical Device Packaging Exp or Pharma Industry Exp
MillenniumSoft Inc · Franklin Lakes, NJ · 5 days ago
Full-time
6-month contract position (W2) based in Franklin Lakes, NJ. Hybrid schedule: three days on-site, two days remote. Open to US Citizens, Green Card holders, GC EAD, OPT, EAD, or CPT. Relocation assistance not provided.
About the Role
Mid-level Packaging Engineer within the Packaging COE (R&D) department of a medical-device company. The role focuses on packaging design, development, verification, and validation for medical devices under design-control processes.
Requirements
- Bachelor’s degree (or equivalent) in Packaging, Mechanical Engineering, Materials Engineering, or a related field.
- Minimum 3 years of experience in medical-device or pharmaceutical packaging.
- Hands-on experience with:
- Packaging design & development for medical devices or pharma.
- Packaging verification & validation for medical devices or pharma.
- Design-control processes for medical devices.
- Packaging standards and regulatory requirements (ISO 11607, EU MDR, etc.).
Responsibilities
- Apply packaging-engineering principles to design, prototype, and qualify new packaging concepts under design-control requirements with moderate guidance.
- Evaluate and improve existing packaging concepts with moderate guidance.
- Identify, analyze, and specify standard packaging materials and equipment.
- Support external contractors/resources as needed.
- Communicate technical knowledge effectively and validate understanding of packaging test methods, standards, and related equipment.
- Develop medical-device packaging systems for flexible and rigid applications.
- Conduct packaging-system verification and validation.
- Utilize CAD tools for packaging design and apply statistics/design-of-experiments methodologies.
- Adhere to client Quality and Corporate Policies; no direct reports or functional-area responsibility.
Skills
- Proficiency with CAD tools for packaging design.
- Experience with statistics and design of experiments.
- Knowledge of ISO 11607, ISO 13485, and ISO 14971 standards.
Schedule
- Full-time: 40 hours/week, 1st shift.
- Hybrid model: three days on-site, two days remote.