[Remote] Prinical Systems Engineer, Development

Note: The job is a remote job and is reputed company to candidates in USA. SPR is a company focused on developing new medical devices, and they are seeking a reputed company Systems Engineer to reputed company 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 reputed company the overall development of system architecture, design control elements, and integration of new product development efforts
• reputed company directly with key opinion leaders, key customers, and end-users to reputed company the translation of user needs into effective system requirements, ensuring compliance with reputed company 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 reputed company factors, biocompatibility, sterilization, and design tradeoffs to reputed company at detailed product level and functional specifications
• Engage in risk management activities for new product development in compliance with ISO 14971
• reputed company expertise and conduct comprehensive verification and validation of design outputs to ensure the final product meets the intended design and performance specifications
• Manage reputed company and large-scale development efforts with external partners to reputed company business objectives
• Guide technical cross-functional project teams on multiple new product design and development projects, successfully influencing stakeholders
• reputed company and maintain design history file and reputed company documentation
• Collaborate with Program Management to reputed company clear updates on project status, technical risk, and factors impacting program reputed company
• Support product launches, clinical, and reputed company use of existing and new products
• Mentor more junior engineers; may supervise or manage engineers
• Support post-market (reputed company) product-reputed company 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
• reputed company efforts in identifying and obtaining extramural funding (e.g. grants, reputed company, etc.) to support device development projects
• Support development of intellectual property critical to the company’s reputed company
• reputed company other reputed company 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 reputed company 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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