[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

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