Sr Principal Engineer, Product Development

Scorpion Therapeutics; Mansfield (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Principal Engineer to lead design of electromechanical and electro-fluidic medical devices, with emphasis on neurosurgical and critical care technologies. You will direct experimental programs within a QMS, oversee ISO 10993 biocompatibility work, and build data platforms using Python.

The role requires extensive experience in FDA-regulated medical device development, embedded systems, and polymer design, with a focus on cross-functional collaboration

Qualifications

• Bachelor's degree with 15+ years in Mechanical, Systems, or Electrical Engineering.
• Experience in FDA-regulated medical device development (21 CFR Part 820, ISO 13485).
• Proficiency in Python, CAD, and polymer design is expected.

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 for device data.
• Apply DFM principles to polymer device components.
• Create detailed 3D models and GD&T drawings.
• Evaluate bio-fluid dynamics for device performance.
• Communicate complex data to cross-functional teams.
• Mentor junior engineers.
• Support regulatory documentation and interactions.

Skills

Sensor data acquisition

Embedded systems

Signal processing

Python programming

Cross-functional communication

Mentoring

Education

Bachelor's degree in Mechanical/Systems/Electrical Engineering

Master's degree in Mechanical/Systems/Electrical Engineering

PhD in Mechanical/Systems/Electrical Engineering

Tools

SolidWorks

Data acquisition hardware

MEMS sensors

Job description

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
• 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
• statistical methods

Work setup

Hybrid (Mansfield, MA or Princeton, NJ).

High-value biopharma specifics

• device development at early feasibility to verification stages
• regulatory compliance
• cross-disciplinary collaboration