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Spacelabs Healthcare, LLC Principal NPI Engineer in Snoqualmie, Washington

Job Description Overview At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. Why work at Spacelabs? Because lives depend on you! We are seeking a highly skilled and motivated Senior NPI Project Engineer to join our dynamic team and play a pivotal role in the successful launch of new products. As a Principal NPI Project Engineer, you will lead and manage the New Product Introduction (NPI) process for our innovative medical devices. You will collaborate closely with cross-functional teams, including R&D, Manufacturing, Quality, Regulatory Affairs, and Supply Chain, to ensure seamless product development and commercialization. Your expertise in project management, engineering principles, and medical device regulations will be essential in driving the successful launch of new products that meet the highest quality and safety standards. Responsibilities Lead the end-to-end NPI process for new medical device products, from prototype through commercialization, ensuring compliance with regulatory requirements and quality standards. Work cross functionally to ensure the development of comprehensive project plans, schedules, and budgets. Build the KPIs and deliverables for the PMO team to drive and maintain. Own the Engineering relationships between R&D and Operations/Mfg. Work closely within the X-functional team to secure and properly integrate OEM supplied deliverables. Work Closely with Regulatory/Compliance teams to ensure Global and Domestic standards are secured and documented. Originate, Model and teach GMP efforts related to change management and Design Controls. Work with PMO and external suppliers to track progress against key milestones. Work with Management to enhance current process and methods to ensure deliverables are met. Identify potential risks and issues that may impact project timelines, budgets, or product quality, and implement proactive mitigation strategies. Collaborate with R&D, Operations and RA/QA teams to translate product designs into manufacturable solutions, optimizing for cost, quality, and manufacturability. Work closely with Manufacturing and Supply Chain teams to ensure smooth scale-up and transfer of new products to production. Ensure compliance with relevant regulatory standards (e.g., FDA, ISO) and drive the preparation of necessary documentation for regulatory submissions. Drive continuous improvement initiatives to enhance NPI processes, streamline workflows, and increase efficiency. Provide technical mentorship and guidance to junior engineers, sharing best practices and promoting professional growth. Collaborate with external partners, suppliers, and contract manufacturers to facilitate successful NPI execution. Participate in risk assessments, design reviews, and quality control activities to ensure the highest level of product quality and patient safety. Qualifications Bachelor\'s or Master\'s degree in Biomedical Engineering, Mechanical Engineering, or related field. 12+ years of experience in NPI project engineering roles within the medical device industry. Strong understanding of medical device regulations (FDA, ISO) and quality management systems. Proven track record of successfully managing and delivering NPI projects on time and within budget. Proficiency in project management software tools and methodologies. Excellent problem-solving and critical-thinking skills, with a focus on data-driven decision-making. Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and external partners. Command of design