SPR · 2 weeks ago
Principal Systems Engineer, New Product Development
United States
Full-time
Remote
Lead/Staff
$140K/yr - $160K/yr
10+ years expSPR is seeking a Principal Systems Engineer to provide technical leadership in the definition, architecture, and integration of complex medical devices throughout the product lifecycle. This role involves translating customer needs into clear requirements and leading cross-functional teams to ensure compliance with regulatory standards.
HealthcareBiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Provide technical leadership for systems engineering activities across multiple projects and teams throughout the product lifecycle
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
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 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
Lead system-level design reviews, tradeoff and integration discussions, maintaining documentation within the Design History File (DHF)
Mentor and coach junior engineers, establishing best practices in systems engineering, systems thinking, documentation, and verification activities
Identify opportunities for process improvement and contribute to the development of best practices
Qualification
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
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
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
Company
SPR
SPR provides patients with a non-opioid, minimally invasive pain treatment option.
201-500 employees
Funding
Current Stage
Late StageTotal Funding
$188.76MKey Investors
Revelation PartnersSLR Capital PartnersU.S. Department of War
2026-04-25Acquired
2024-02-01Series D· $25M
2024-02-01Debt Financing· $60M
Leadership Team
Maria Bennett
President, CEO & Founder
Joseph Boggs
Chief Scientific Officer (CSO) and Senior Vice President (SVP), Research and Development (R&D)
Recent News
Medical Device Network
2026-07-28
BioWorld Financial Watch
2026-07-25
BioWorld Financial Watch
2026-07-21
Company data provided by crunchbase