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Position Summary

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.

Key Responsibilities

• 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 ASME Y14.5 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.

Required Qualifications

• Bachelor's degree or equivalent with 15+ years of experience; Master's degree with 12+ years of experience; Ph.D. with 10+ years of experience in Mechanical Engineering, Systems Engineering, Electrical Engineering, or a closely related technical discipline.
• Minimum of 10 years of progressive hands-on experience in medical device product development under FDA Quality System Regulation (21 CFR Part 820) and ISO 13485, with a demonstrated track record of successfully advancing complex electromechanical or electro-fluidic devices from concept through verification, validation, and commercialization.
• Proven expertise in the design, implementation, and troubleshooting of analog-to-digital data acquisition systems, including error analysis, signal conditioning, filtering, and processing for sensor-based medical devices.
• Strong proficiency in Python for scientific computing and data analysis; demonstrated ability to prototype signal-processing algorithms, process large multi-format datasets, and produce clear visualizations.
• Hands-on experience developing and deploying embedded systems and automated test equipment using microcontrollers, with working knowledge of communication protocols such as RS-485, CAN-Bus, and Bluetooth.
• Solid background in Design for Manufacturability (DFM) for medical-grade polymeric devices, including injection molding, additive manufacturing, CNC machining, material selection, and adhesive bonding strategies suitable for fluid-contact or long-term use applications.
• Expert-level proficiency in 3D CAD modeling (SolidWorks preferred) and creation of 2D engineering drawings with proper GD&T application.
• Strong working knowledge of bio-fluid mechanics, particularly at mesofluidic and microfluidic scales, with ability to apply principles to device design and testing.
• Excellent verbal and written communication skills with proven ability to distill highly technical engineering information into clear, concise, and actionable content for diverse stakeholders.

Preferred Qualifications

• Hands-on experience with Computational Fluid Dynamics (CFD) simulations and Finite Element Analysis (FEA), especially for failure analysis or performance prediction of polymeric materials.
• Practical experience with MEMS sensor technologies, with strong preference for piezoresistive pressure sensing; familiarity with microfabrication processes from wafer-level processing through die attach and wire bonding.
• Solid foundation in inorganic and organic chemistry as applied to medical device materials, surface interactions, degradation mechanisms, and leachables/extractables considerations.
• Experience supporting or leading elements of regulatory submissions (e.g., 510(k), De Novo, PMA) and participating in FDA or notified body audits.
• Formal training in statistical methods, Design of Experiments (DOE), or Six Sigma (Green Belt or Black Belt).

Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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