Prinical Systems Engineer, New Product Development

The Principal Systems Engineer provides technical leadership in the definition, architecture, and integration of complex medical devices and systems throughout the full product lifecycle, from concept through commercialization and sustaining support. This role translates customer and stakeholder needs into clear, verifiable system and product requirements, ensuring alignment with user needs, regulatory expectations, and business objectives. The Principal Systems Engineer acts as a key interface between cross-functional teams, leading system-level requirements development system level risk management activities in collaboration with Quality, and system integration efforts to deliver safe, effective, and compliant medical products.

Ideally, this candidate will reside near one of our corporate locations: Cleveland, OH; Chapel Hill, NC; Brooklyn Park, MN

PRIMARY RESPONSIBILITIES

1. Provide technical leadership for systems engineering activities across multiple projects and teams throughout the product lifecycle 
2. Serve as a subject matter expert (SME) in systems engineering methodologies, requirements management, and system integration best practices.
3. Translate voice of customer and stakeholder needs into clear, measurable, and verifiable system and product requirements 
4. Define, develop, and maintain system architecture, including hardware, software, and interfaces, ensuring design traceability through trace matrices and interface specifications across subsystems.
5. Plan and drive system integration activities, coordinating subsystem development, interface management, and verification efforts to ensure cohesive system performance.
6. Engage in and provide technical leadership for system level risk management activities, including failure mode effect analysis (FMEA), hazard analysis, and fault tree analysis in alignment with ISO 14971 and related standards.
7. Oversee system verification and validation (V&V) activities, ensuring complete test coverage against requirements and compliance with applicable standards.
8. Lead and collaborate with technical teams and external partners, influencing technical direction, ensuring design traceability, and driving system-level integration and compliance with functional, quality, and regulatory requirements.
9. Lead system-level design reviews, tradeoff and integration discussions, maintaining documentation within the Design History File (DHF) 
10. Mentor and coach junior engineers, establishing best practices in systems engineering, systems thinking, documentation, and verification activities.
11. Identify opportunities for process improvement and contribute to the development of best practices.

KNOWLEDGE AND SKILL REQUIREMENTS 

• Bachelor’s Degree in Engineering discipline (Systems, Mechanical, Electrical, or related field).
• Typically 10+ years of experience (or equivalent combination of experience and education)
• In-depth knowledge of medical device development, system engineering principles, and relevant technologies.
• Strong understanding of FDA regulations and international standards for medical devices (ISO 13485, ISO 14971, IEC 60601, IEC 62304).
• Expertise in system integration, interface management, and system verification & validation testing.
• Proven experience conducting risk assessments and implementing mitigation strategies in compliance with ISO 14971.
• Demonstrated ability to lead technical teams, influence stakeholders, and make data-driven technical decisions.
• Strong organizational skills with the ability to manage multiple priorities and deliver results on schedule.
• Proficient in developing and executing comprehensive verification and validation plans.
• Strong self-starter, who is also an effective team player, organized, and must be able to manage multiple projects and meet established timelines.
• Excellent organizational, interpersonal, oral, and written communications skills

PREFERRED QUALIFICATIONS

• Direct, hands-on system engineering experience developing and integrating Class III and/or Active Implantable Medical Device (AIMD) neurostimulation systems is a plus.
• INCOSE certification (ASEP, CSEP, or ESEP) is a plus.
• Design for Six Sigma (DFSS) certification (Green Belt, Black Belt, or equivalent) is a plus.
• Familiarity with INCOSE systems engineering standards and practices

WORKING CONDITIONS

• Small office environment, electrical and mechanical prototyping labs.
• Ability to effectively work in a "virtual environment" at home or at a centrally located office
• Comfortable and productive working in and contributing to small engineering teams.
• Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs
• Periodic travel, such as supplier visits, can usually be planned in advance.