Sr Principal Engineer, Product Development

Role: Senior Principal Engineer in medical devices focusing on electromechanical and electro-fluidic systems, with emphasis on neurosurgical, critical care, and fluid-management technologies. Responsibilities: lead design and execution of experimental programs within a QMS, oversee biocompatibility testing per ISO 10993, develop analog-to-digital data acquisition systems, build Python data platforms, apply DFM principles to polymer device components, create detailed 3D models and drawings with GD&T, evaluate bio-fluid dynamics for device performance, communicate complex data to cross-functional teams, mentor junior engineers, and support regulatory documentation and interactions. Qualifications: Bachelor's degree with 15+ years, Master's with 12+ or Ph.D. with 10+ years in Mechanical, Systems, or Electrical Engineering; extensive experience in FDA-regulated medical device development (21 CFR Part 820, ISO 13485); expertise in sensor data acquisition, embedded systems, and signal processing; proficiency in Python, CAD (SolidWorks preferred), and medical-grade polymer design; knowledge of bio-fluid mechanics. Preferred: CFD and FEA simulations, MEMS sensor technologies, materials chemistry, regulatory submission experience, and statistical methods. Work setup: Hybrid (Mansfield, MA or Princeton, NJ). High-value biopharma specifics include device development at early feasibility to verification stages, regulatory compliance, and cross-disciplinary collaboration.