Job Title: R&D/Product Development Engineer - Engineer III

Location: Branchburg, NJ (Hybrid)

Duration: Long Term

Overview:

Seeking a mid-level Engineer with strong experience in medical device product development, focusing on design controls, verification & validation, and laboratory testing within a regulated environment.

Required Experience:

• Bachelor’s degree with 5+ years or Master’s with 3+ years of relevant experience
• Experience in new product development (NPD) and defining user/technical requirements
• Hands-on experience with design controls (Design Verification & Validation - DV/IV)
• Experience in laboratory testing and statistical data analysis (MiniTab/JMP)
• Experience with Design History File (DHF) documentation
• Experience supporting medical device regulatory submissions
• Knowledge of GxP/regulatory compliance standards

Key Responsibilities:

• Collaborate with cross-functional teams (R&D, Quality, Regulatory) on product development projects
• Define product requirements and support design and development activities
• Develop and execute Design Verification & Validation strategies
• Perform lab testing, analyze data, and support design decisions
• Create and manage protocols, reports, and DHF documentation
• Support prototyping and product development activities
• Ensure compliance with quality and regulatory standards