Talent.com
Principal Systems Engineer (Andover)
Principal Systems Engineer (Andover)Digital Health Solutions • Andover, MA, US
Principal Systems Engineer (Andover)

Principal Systems Engineer (Andover)

Digital Health Solutions • Andover, MA, US
20 days ago
Job type
  • Part-time
Job description

Principal Systems Engineer

Location : Andover, MA (In-person)

Company Overview

Digital Health Solutions (DHS) is a premier consulting firm dedicated to advancing medical device innovation. We partner with companies across the medical technology spectrum to deliver safe, effective, and compliant solutions. With deep expertise in IEC 62304, ISO 13485, and FDA / EU regulatory frameworks, DHS helps clients accelerate product development while ensuring patient safety and clinical impact remain at the core. Our mission is simple yet powerful : to guide the development of medical technologies that improve and save lives.

Position Overview

We are seeking an accomplished Principal Systems Engineer to join our growing team. This role is ideal for a highly experienced systems thinker who thrives at the intersection of engineering, clinical application, and regulatory compliance. The Principal Systems Engineer will lead complex projects across Class II and III medical devices, bringing together cross-functional teams to deliver innovative solutions in areas such as neurostimulation, cardiac support, and medical imaging.

At DHS, you wont just contribute technical, you will shape strategy, mentor emerging engineers, and influence the next generation of patient-focused technology. This is a hands-on leadership role where youll translate clinical needs into actionable requirements, architect and validate systems, and drive design control excellence from concept through commercialization.

We are looking for a candidate who combines technical depth, regulatory fluency, and leadership presence . The ideal candidate is someone who can balance innovation with compliance, build consensus across diverse stakeholders, and drive projects to successful completion in fast-paced environments.

Key Responsibilities

  • Lead systems engineering activities across the full product lifecycle, from concept through verification, validation, and commercialization.
  • Translate user and clinical needs into system, subsystem, and component requirements while maintaining rigorous traceability.
  • Participate in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.
  • Ensure requirements can be verified in compliance with design controls and other QMS SOPs.
  • Architect system-level solutions, define interfaces, and guide trade-off analyses to achieve optimal design outcomes.
  • Oversee risk management activities (HA, FMEA, risk-benefit analysis) ensuring compliance with ISO 14971 and related standards.
  • Direct verification and validation strategies, author test protocols / reports, and coordinate testing with external labs.
  • Drive design control documentation and ensure adherence to ISO 13485, IEC 60601, IEC 62304, and FDA / EU regulations.
  • Collaborate cross-functionally with clinical, quality, regulatory, and manufacturing teams to resolve conflicts and ensure alignment.
  • Mentor junior engineers, fostering professional growth and building DHSs technical leadership bench.
  • Contribute to program management activities including project planning, deliverable tracking, and executive reporting.
  • Support business development efforts through technical input to proposals, client engagement, and thought leadership.

Preferred Qualifications

  • Masters degree in Biomedical, Electrical, Systems, or related Engineering field (PhD a plus).
  • 10+ years of experience in systems engineering within Class II / III medical devices.
  • Proven track record in requirements management, system architecture, and verification / validation.
  • Strong knowledge of regulatory compliance (FDA 21 CFR Part 11 / 820, EU MDR, ISO 13485, IEC 60601, IEC 62304, ISO 14971).
  • Experience leading cross-functional teams, managing CAPAs, and closing complex regulatory gaps.
  • Skilled in tools such as JIRA, Confluence, and test management platforms.
  • Strong interpersonal skills with the ability to communicate effectively across technical and non-technical audiences.
  • What We Offer

  • Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
  • The opportunity to work on cutting-edge medical technologies that directly improve patient lives.
  • Exposure to a broad range of projects and modalities , from implantable devices to advanced imaging systems.
  • Mentorship and collaboration with leading experts in systems engineering, regulatory affairs, and product development.
  • A role where your technical leadership and strategic insight shape both client success and DHSs growth.
  • The satisfaction of delivering solutions that balance innovation, compliance, and patient safety making a tangible impact in healthcare.
  • Create a job alert for this search

    Principal System Engineer • Andover, MA, US

    Related jobs
    Senior Systems Engineer-Space and Mission Critical Systems

    Senior Systems Engineer-Space and Mission Critical Systems

    Draper Labs • Cambridge, MA, United States
    Full-time
    Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...Show more
    Last updated: 30+ days ago • Promoted
    Senior Systems Engineer

    Senior Systems Engineer

    DEKA Research and Development • Manchester, NH, United States
    Full-time
    DEKA Research & Development, located in Manchester, NH, is seeking a Senior Systems Engineerto join amulti-disciplinary team for a medical device product development program.This excitingopportunit...Show more
    Last updated: 30+ days ago • Promoted
    Senior Systems Engineer

    Senior Systems Engineer

    VirtualVocations • Lowell, Massachusetts, United States
    Full-time
    A company is looking for a Staff Advanced Concepts Systems Engineer.Key Responsibilities Lead the creation of mission concepts, reference architectures, and CONOPS for future space missions Inte...Show more
    Last updated: 30+ days ago • Promoted
    Principal Systems Engineer for Embedded Microsystems Architecture and Design

    Principal Systems Engineer for Embedded Microsystems Architecture and Design

    Draper Labs • Cambridge, MA, United States
    Full-time
    Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...Show more
    Last updated: 30+ days ago • Promoted
    IT Systems Engineer

    IT Systems Engineer

    VirtualVocations • Dorchester, Massachusetts, United States
    Full-time
    A company is looking for an IT System Engineer to manage and optimize productivity tools for its global workforce.Key Responsibilities Administer enterprise tools like Slack and Google Workspace ...Show more
    Last updated: 30+ days ago • Promoted
    System Engineer

    System Engineer

    VirtualVocations • Manchester, New Hampshire, United States
    Full-time
    A company is looking for a System Engineer to design, implement, and manage complex systems infrastructure.Key Responsibilities Lead the design, implementation, and management of complex systems ...Show more
    Last updated: 30+ days ago • Promoted
    Principal Sensor Systems Engineer

    Principal Sensor Systems Engineer

    Draper Labs • Cambridge, MA, United States
    Full-time
    Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...Show more
    Last updated: 30+ days ago • Promoted
    Principal Integration and Test Systems Engineer

    Principal Integration and Test Systems Engineer

    Draper Labs • Cambridge, MA, United States
    Full-time
    Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...Show more
    Last updated: 30+ days ago • Promoted
    Principal Engineer - IAM

    Principal Engineer - IAM

    VirtualVocations • Dorchester, Massachusetts, United States
    Full-time
    A company is looking for a Principal Engineer - Identity Management (IAM & Golang Backend).Key Responsibilities Architect and design the next-generation identity platform for authentication and a...Show more
    Last updated: 4 days ago • Promoted
    Senior Systems Applications Engineer (GMSL)

    Senior Systems Applications Engineer (GMSL)

    1010 Analog Devices Inc. • Wilmington, MA, United States
    Full-time +1
    NASDAQ : ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologie...Show more
    Last updated: 9 days ago • Promoted
    Systems Engineer

    Systems Engineer

    DEKA Research and Development • Manchester, NH, United States
    Full-time
    DEKA Research & Development is seeking a dynamic, results driven, and inventive Systems Engineer to assist in the development of a groundbreaking technologies. This is a great opportunity to roll up...Show more
    Last updated: 30+ days ago • Promoted
    Systems Engineer I

    Systems Engineer I

    VirtualVocations • Manchester, New Hampshire, United States
    Full-time
    A company is looking for a Systems Engineer I to support, maintain, and enhance the systems infrastructure.Key Responsibilities Provide technical support by minimizing end user impacts during sof...Show more
    Last updated: 8 hours ago • Promoted • New!
    Systems Engineer, Principal - TS

    Systems Engineer, Principal - TS

    DCS Corporation • Bedford, MA, United States
    Full-time
    DCS has an exciting opportunity for a.Command, Control, Communications, and Battle Management Division (C3BM).Command, Control, Communications, and Battle Management (C3BM) has been tasked with del...Show more
    Last updated: 30+ days ago • Promoted
    Principal Cloud Engineer

    Principal Cloud Engineer

    Raft • Hanscom Air Force Base, MA, United States
    Full-time
    All of the programs we support require.All work must be conducted within the continental U.Distributed Data Systems, Platforms at Scale, and Complex Application Development, with headquarters in Mc...Show more
    Last updated: 30+ days ago • Promoted
    Systems Engineer, Senior - TS

    Systems Engineer, Senior - TS

    DCS Corporation • Bedford, MA, United States
    Full-time
    DCS has an exciting opportunity for a.GEOINT) in support of intelligence network operations, to join the AFLCMC / HBGW Intelligence Surveillance and Reconnaissance (ISR) Team at Hanscom AFB.The assig...Show more
    Last updated: 25 days ago • Promoted
    Principal Engineer

    Principal Engineer

    VirtualVocations • Manchester, New Hampshire, United States
    Full-time
    A company is looking for a Principal Engineer to work remotely in France.Key Responsibilities Design and develop advanced engineering solutions Collaborate with cross-functional teams to impleme...Show more
    Last updated: 30+ days ago • Promoted
    Principal System Integration and Test Engineer

    Principal System Integration and Test Engineer

    Draper Labs • Cambridge, MA, United States
    Full-time
    Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...Show more
    Last updated: 17 days ago • Promoted
    Systems Engineer

    Systems Engineer

    VirtualVocations • Lowell, Massachusetts, United States
    Full-time
    A company is looking for a Systems Engineer to design, secure, and manage their technical infrastructure.Key Responsibilities Implement and maintain secure infrastructure across cloud, on-prem, a...Show more
    Last updated: 30+ days ago • Promoted
    Principal Systems Application Engineer

    Principal Systems Application Engineer

    1010 Analog Devices Inc. • Wilmington, MA, United States
    Full-time +1
    NASDAQ : ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologie...Show more
    Last updated: 26 days ago • Promoted
    Principal System Concepts Engineer

    Principal System Concepts Engineer

    Draper Labs • Cambridge, MA, United States
    Full-time
    Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...Show more
    Last updated: 30+ days ago • Promoted