Principal Systems Engineer

Job Description

Title : Principal Systems Engineer

Location : Andover MA (onsite 5x / week)

Industry : Medical Device company

FULLTIME

Responsibilities

• Serve as the primary technical bridge between sensor technology partners and internal multidisciplinary teams
• Offer expert-level input on system architecture decisions and evaluate design trade-offs
• Own the technical roadmap and integration of biosensors and subsystems across the product portfolio
• Oversee collaborations with external engineering and design vendors, monitoring progress against requirements, schedules, and quality benchmarks
• Convert clinical and functional needs into system architectures and clearly defined, testable specifications
• Drive design reviews, risk analyses, and integration strategies across electrical, mechanical, biochemical, software, and fluidic domains
• Direct verification and validation efforts to confirm subsystem performance and overall system interoperability
• Maintain alignment with relevant regulatory frameworks and standards, including ISO 13485, IEC 60601, and FDA expectations
• Partner with internal R&D, clinical, regulatory, and software groups to achieve development milestones
• Contribute to additional organizational responsibilities and assignments as needed