[Remote] Prinical Systems Engineer, Development

Note:The job is a remote job and is open to candidates in USA. SPR 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. 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 Skills • 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 Overview • SPR is a privately held medical device company, providing patients with a non-opioid, minimally invasive pain treatment option.It was founded in 2010, and is headquartered in Cleveland, Ohio, USA, with a workforce of 201-500 employees. Its website is Apply tot his job