Mechanical Engineer

Responsibilities Translate product requirements into manufacturable mechanical designs Create and maintain CAD models, assemblies, and engineering drawings (SolidWorks preferred) 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 Preferred 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 #J-18808-Ljbffr Roc Search