R&D Engineer (Packaging)

Pentangle Tech Services | P5 Group; Franklin Lakes (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Pentangle Tech Services | P5 Group seeks a Packaging Engineer to assess packaging requirements for medical devices, including sterilized and non-sterile components, and coordinate with vendors.

The role covers design verification activities, creating test strategies, DHF management, and familiarity with ISO 13485 and FDA CFR Part 820 while collaborating across cross-functional teams.

Qualifications

• Familiarity with system engineering practices for medical devices
• Experience with combination device development
• Understanding of design inputs and outputs
• Experience with CAD tools (SolidWorks)

Responsibilities

• Work with vendors to provide packaging specifications for components
• Review and approve packaging design provided by vendors
• Coordinate prototype development for packaging
• Analyze engineering work orders and apply system engineering practices for medical devices
• Support design verification activities including plans, reports, and DHF management

Skills

Stakeholder management

Attention to detail

Communication skills

Prioritization

Education

Bachelor Degree in Packaging / Industrial Engineering

Tools

SolidWorks

Minitab

Job description

Job Description & Skill Requirement

Understanding of Packaging requirements, Requirement Analysis, Review Feasibility for:

• Medical Device - Sterilized Packaging

Job Description & Skill Requirement

Understanding of Packaging requirements, Requirement Analysis, Review Feasibility for:

• Medical Device - Sterilized Packaging
• Non Sterile Component Packaging

Work With Vendors For Packaging Components

• Provide packaging Specifications to the Vendors
• Review and approve packaging design provided by Vendors
• Coordinate Prototype Development

Analysis Of Engineering Work Orders

• Familiarity in System Engineering practices and principles for medical devices
• Experience with combination device development
• Differences in Drawing/Document Revisions and its impact
• Engineering Documentation
• Design Input and Outputs
• Knowledge of CAD Tools - Solid Works

Work On Design Verification Activities

• Design Verification Plan and Report
• Test Strategies
• Test Methods
• DHF Management
• Basic knowledge of Statistics, Sampling Plan
• Experience with Minitab for data analysis

Knowledge Of Standards

• Design Controls – ISO 13485, FDA CFR Part 820
• Awareness of ISO11607, ASTM D4169

Other Skills

• Stake holder management and ability to work within the Cross Functional Team
• Thorough and Detail oriented
• Excellent Communication - Verbal and Written
• Ability to prioritize

Qualification:

Bachelor Degree in Packaging / Industrial Engineering, or other engineering discipline