Product Development Engineer

The Product Development Engineer supports new product development and commercialization by executing engineering tasks, testing, documentation, data analysis, equipment qualification, and design control activities in a regulated medical/pharmaceutical environment.

Key Responsibilities

• Support new product development using engineering fundamentals.
• Install, qualify, and support R&D equipment.
• Perform engineering testing, data analysis, and technical report writing.
• Develop and validate test methods for materials and inspections.
• Maintain Design History Files (DHF) and support DFMEA/risk management.
• Prepare DMR documentation such as specifications, test methods, and manufacturing instructions.
• Participate in design reviews, root cause analysis, and failure investigations.
• Support technology transfer and process validation for new product launch.
• Ensure compliance with FDA regulations, and safety procedures.

Required Skills

• BS in Engineering; Mechanical or Biomedical preferred.
• Good understanding of design control and quality systems.
• Knowledge of statistics: Gage R&R, capability analysis, DoE, normality, acceptance sampling.
• Experience with technical writing and data analysis.
• Familiarity with FDA-regulated environments: 21 CFR 211, 21 CFR 820, ISO 13485.
• Knowledge of root cause analysis tools like 5 Whys and Ishikawa.
• Proficiency in Excel/Minitab.

For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com.