Senior Systems Engineer

Job Title: Senior Systems Engineer  

Job Description

The Senior Systems Engineer applies cross-functional expertise in electronics, software, and mechanical technologies to lead the specification, architecture, design, implementation, and testing of embedded medical devices. This role owns substantial assignments across all levels of system architecture on projects of moderate to high complexity and requires creativity, ingenuity, and strong technical leadership throughout the full product lifecycle from concept through transfer to manufacturing.

Responsibilities

• Lead cross-functional technical teams in delivering embedded medical devices from initial customer requirements through detailed design, implementation, verification, and transfer to manufacturing.
• Serve as the primary technical point of contact for customers, representing the engineering team and ensuring clear communication of technical status, risks, and decisions.
• Define overall system architecture and maintain accountability for system-level design documentation, ensuring traceability from requirements through implementation and test.
• Lead the evaluation of design alternatives and perform trade-off analyses across electronics, software, and mechanical technologies to achieve optimal system solutions.
• Drive the definition, analysis, and allocation of system and subsystem requirements derived from customer and user needs, regulatory requirements, and applicable standards.
• Oversee risk management activities, including planning, execution, and maintenance of design failure modes and effects analysis (DFMEA) and related risk documentation.
• Serve as the project’s primary technical authority on applicable medical industry standards and ensure designs comply with relevant regulations and guidelines.
• Partner with test engineering to define verification and validation strategies and procedures that demonstrate compliance with system requirements.
• Coordinate and manage third-party engagements, including outsourced design activities and external testing services, ensuring alignment with project goals and quality expectations.
• Lead schedule development and budget estimation for new project opportunities, contributing to proposals and project planning activities.
• Provide mentorship, coaching, and technical guidance to less experienced engineers, fostering knowledge sharing and professional growth within the team.
• Lead and support continuous improvement initiatives across engineering processes, tools, and methodologies to enhance quality and efficiency.
• Operate under general supervision while exercising sound technical judgment, ensuring work products meet engineering standards and project objectives.
• Follow established procedures and engineering practices, contributing to a consistent and compliant development process.

Essential Skills

• Bachelor’s or Master’s degree in Systems, Software, Electrical, or Mechanical Engineering.
• 8+ years of experience developing software-based and/or electronic-based medical devices or other regulated products.
• Proven experience in systems engineering across the entire product lifecycle, from concept and requirements definition through design, verification, and transfer to manufacturing.
• Demonstrated experience serving as one of the primary technical contacts for customer interaction on complex engineering projects.
• Established track record of technical leadership, including leading cross-functional teams and owning system-level decisions.
• Demonstrated complete understanding and wide application of technical principles, theories, and concepts in the field of medical devices, with general knowledge of other engineering disciplines.
• Proficiency in quickly diagnosing and solving medium-complexity system-level problems involving electronics, software, and mechanical components.
• In-depth knowledge of FDA Quality System Regulations (QSRs) and relevant IEC standards for medical devices.
• Experience interpreting and applying technical regulatory requirements to the design and development of medical devices.
• Strong interpersonal and communication skills, including clear written documentation and effective oral communication with technical and non-technical stakeholders.
• Strong analytical skills with the ability to evaluate complex technical trade-offs and make data-driven decisions.
• Ability to work independently with minimal supervision while also functioning effectively as a collaborative team member.

Additional Skills & Qualifications

• Experience in systems integration and working with requirements from multiple stakeholders, including customers, regulatory bodies, and internal teams
• Background in electrical engineering, software engineering, or related disciplines with hands-on exposure to embedded systems.
• Experience ensuring regulatory compliance throughout the development process for medical or other regulated devices.
• Familiarity with coordinating outsourced design activities and external testing laboratories.
• Experience leading or contributing to continuous improvement initiatives in engineering processes and tools.
• Demonstrated ability to build strong working relationships with multidisciplinary teams and clients.
• Comfort working in a dynamic environment with a variety of projects and technologies.