Senior Systems Engineer

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.
• Partner with test engineering to define verification and validation strategies and procedures that demonstrate compliance with system requirements.
• Cover coordination and management of 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.

Requirements

• 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.