Mechanical Engineer in Newark

Job Description

Responsibilities

Mechanical Design & Product Development

• Translate product requirements into manufacturable mechanical designs
• Create and maintain CAD models, assemblies, and engineering drawings (SolidWorks )
• Support prototyping, engineering builds, and pilot production activities
• Drive DFM/DFA initiatives with vendors and manufacturing partners
• Participate in design reviews and technical problem solving
• Support development of miniaturized electromechanical systems
• Consider reliability, durability, and environmental protection requirements

Documentation & Design Controls

• Develop and maintain product requirements and engineering documentation
• Support Design History File (DHF) activities and regulated product development processes
• Participate in risk assessments and DFMEA activities
• Ensure design outputs meet quality and regulatory requirements

Required Qualifications

• Bachelor's degree in Mechanical Engineering or related field
• 4+ years of experience in medical devices or another highly regulated industry
• Strong SolidWorks or 3D CAD experience
• Experience working within design controls or regulated development environments
• Experience with verification testing and test fixture development
• Hands-on prototyping experience
• Experience working with vendors, suppliers, and manufacturing partners
• Strong troubleshooting and root cause analysis skills
• Ability to work onsite in Newark, NJ several days per week

Qualifications

• Wearable, sensor-integrated, or miniaturized product experience
• Design transfer and manufacturing support experience
• Injection molding, adhesives, sealing methods, and precision assembly knowledge
• DFMEA and risk management experience
• Startup or early-stage company experience
• 3D printing and rapid prototyping experience
• Familiarity with statistical analysis and reliability testing method