Sr Principal Engineer, Product Development

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

We are seeking a highly accomplished Senior Principal Engineer to serve as a senior technical leader and individual contributor in the development of advanced medical devices featuring complex electromechanical and electro-fluidic systems. This role focuses on neurosurgical, critical care, and fluid-management technologies, with deep expertise spanning sensor integration, signal processing, embedded systems, polymer device design and manufacturing, biocompatibility, and rigorous application of design controls.

The ideal candidate will drive projects from early feasibility through design verification, validation, regulatory submission, and manufacturing transfer while mentoring junior engineers and serving as a key technical resource for cross-functional teams. This position requires exceptional hands‑on technical depth combined with strong communication skills to translate complex engineering concepts into clear, actionable insights.

Location:

Hybrid; candidates able to work from Mansfield, MA or Princeton, NJ.

• Lead the design and execution of comprehensive experimental programs within a medical device Quality Management System, guiding projects from initial investigation and feasibility through formal design verification and validation (V&V) in full compliance with FDA 21 CFR Part
  820 design controls and ISO
  13485.
• Plan, coordinate, and execute biocompatibility evaluation programs per the ISO
  10993 series in close collaboration with toxicologists, analytical chemists, and regulatory partners; interpret results, support risk management files, and contribute to regulatory submissions.
• Architect, design, prototype, and validate analog‑to‑digital data acquisition systems for medical device development and automated testing, including detailed error propagation analysis, ADC characterization, analog and digital filtering, and advanced signal‑processing techniques.
• Develop and maintain Python‑based data processing platforms to prototype signal‑processing algorithms, efficiently ingest and analyze large heterogeneous datasets from mixed file types, perform statistical analysis, and generate clear visualizations that drive technical decision‑making.
• Apply Design for Manufacturability (DFM) principles to polymeric medical device components and assemblies, with expertise in design for injection molding, additive manufacturing (3D printing), precision machining of medical‑grade polymers, and selection/validation of appropriate medical‑grade adhesives.
• Create and maintain high‑fidelity 3D solid models and fully dimensioned 2D engineering drawings incorporating Geometric Dimensioning and Tolerancing (GD&T) per ASMEY
  14.5 to ensure designs are robust, manufacturable, inspectable, and functionally sound.
• Apply deep knowledge of bio‑fluid dynamics at mesofluidic and microfluidic scales to inform device architecture, performance optimization, and testing strategies for fluid‑handling medical devices.
• Effectively synthesize, condense, and communicate complex technical data, experimental results, trade‑off analyses, and risk assessments through clear presentations, design reviews, and written reports for cross‑functional audiences including R&D, Quality, Regulatory, Manufacturing, and senior leadership.
• Provide technical mentorship and guidance to junior engineers and technicians; contribute to the establishment of design standards, best practices, and continuous improvement within the R&D organization.
• Support Design History File (DHF) development, risk management activities (ISO
  14971), change control, and interactions with regulatory bodies or notified bodies as needed.

• Bachelor’s degree or equivalent with 15+ years of experience;
  Master’s degree with 12+ years of experience;
  Ph.D. with…