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SPR · 23 hours ago

Principal Systems Engineer, Development

United States

Full-time

Remote

Lead/Staff

10+ years exp

SPR is seeking a Principal Systems Engineer who provides technical leadership in the definition, architecture, and integration of complex medical devices throughout the product lifecycle. The role involves translating customer needs into system requirements, leading cross-functional teams, and ensuring compliance with regulatory standards.

Health CareMedicalTherapeutics

Responsibilities

Provide technical leadership for systems engineering activities across multiple projects and teams throughout the product lifecycle (concept, feasibility, development, verification & validation, transfer to manufacturing, and sustaining)

Serve as a subject matter expert (SME) in systems engineering methodologies, requirements management, and system integration best practices

Translate voice of customer and stakeholder needs into clear, measurable, and verifiable system and product requirements that meet user, business, and regulatory needs

Define, develop, and maintain system architecture, including hardware, software, and interfaces, ensuring design traceability through trace matrices and interface specifications across subsystems

Plan and drive system integration activities, coordinating subsystem development, interface management, and verification efforts to ensure cohesive system performance

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

Oversee system verification and validation (V&V) activities, ensuring complete test coverage against requirements and compliance with applicable standards

Lead system-level design reviews, tradeoff and integration discussions, maintaining documentation within the Design History File (DHF)

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

Mentor and coach junior engineers, establishing best practices in systems engineering, systems thinking, documentation, and verification activities

Provide technical support for the Sales Team, customers, and clinical trial sites as needed

Support post-market (commercial) product-related investigations as well as CAPA and sustaining engineering activities

Identify opportunities for process improvement and contribute to the development of best practices

Perform other related duties as assigned

Qualification

Medical device developmentSystems engineering principlesRisk management activitiesRequirements developmentSystem integrationVerificationValidationFDA regulationsStatistical methodsRequirement management toolsLeadership skillsInterpersonal skillsOrganizational skillsCommunication skillsMentoring skillsTeam player

Required

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

Proven ability to define, model, and manage complex system architectures, balancing tradeoffs among user needs, performance, reliability, and safety

Strong understanding of FDA regulations and international standards for medical devices (ISO 13485, ISO 14971, IEC 60601, IEC 62304)

Demonstrated experience in requirements development, allocation, and verification, including traceability across user, system, and subsystem levels

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

Proficiency with requirement management and systems engineering tools (Jama or equivalent)

Strong foundation in statistical and analytical methods (DOE, reliability analysis, tolerance analysis) to optimize system performance and reliability

Familiarity with INCOSE systems engineering standards and practices

Demonstrated ability to lead technical teams, influence stakeholders, and make data-driven technical decisions

Effective leadership and mentoring skills with the ability to guide less-experienced engineers

Excellent communication and interpersonal skills, capable of collaborating across disciplines and global locations

Strong organizational skills with the ability to manage multiple priorities and deliver results on schedule

Exceptional communication and interpersonal skills, with the ability to collaborate across functions and different locations

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

Direct, hands-on system engineering experience developing and integrating Class III 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