SPR · 3 weeks ago
Prinical Systems Engineer, Development
United States
Full-time
Remote
Lead/Staff
10+ years expSPR is a company focused on developing new medical devices, and they are seeking a Principal Systems Engineer to lead the design and development efforts. This role involves overseeing the development of system architecture, ensuring compliance with industry standards, and mentoring junior engineers.
Health CareMedicalTherapeutics
Responsibilities
Define, design, and lead the overall development of system architecture, design control elements, and integration of new product development efforts
Interface directly with key opinion leaders, key customers, and end-users to lead the translation of user needs into effective system requirements, ensuring compliance with current and emerging industry standards, and overseeing end-to-end traceability between user needs, requirements, test, and risk
Ensure the safety, reliability, and performance of the complete system and sub-systems, considering elements like human factors, biocompatibility, sterilization, and design tradeoffs to arrive at detailed product level and functional specifications
Engage in risk management activities for new product development in compliance with ISO 14971
Provide expertise and conduct comprehensive verification and validation of design outputs to ensure the final product meets the intended design and performance specifications
Manage complex and large-scale development efforts with external partners to achieve business objectives
Guide technical cross-functional project teams on multiple new product design and development projects, successfully influencing stakeholders
Develop and maintain design history file and related documentation
Collaborate with Program Management to provide clear updates on project status, technical risk, and factors impacting program success
Support product launches, clinical, and commercial use of existing and new products
Mentor more junior engineers; may supervise or manage engineers
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
Champion and understand the needs of the patient, provider, and business through an unwavering commitment to patient safety and product quality
Lead efforts in identifying and obtaining extramural funding (e.g. grants, contracts, etc.) to support device development projects
Support development of intellectual property critical to the company’s success
Perform other related duties as assigned
Qualification
Required
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
Proven experience in conducting risk assessments and implementing mitigation strategies in compliance with ISO 14971
Demonstrated ability to manage complex development efforts, including coordination with external partners
Effective leadership skills to guide and mentor less senior team members, with the ability to influence stakeholders
Exceptional communication and interpersonal skills, with the ability to collaborate across functions and geographical locations
Proficient in developing and executing comprehensive verification and validation plans
Company
SPR
SPR is a privately held medical device company, providing 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 Defense
2024-02-01Series D· $25M
2024-02-01Debt Financing· $60M
2021-10-18Series D· $37M
Leadership Team
Maria E. Bennett
President, CEO & Founder
Joseph Boggs
Chief Scientific Officer (CSO) and Senior Vice President, Research and Development
Recent News
2025-12-15
SPR Therapeutics, Inc.
2025-07-17
Company data provided by crunchbase