<p>About This Role The Senior Principal Manufacturing Engineer is a technical leader responsible for designing, scaling, and optimizing advanced manufacturing systems for medical devices, with a strong emphasis on high-volume automation. This role bridges complex product design with efficient, compliant, large-scale production, leading end-to-end manufacturing strategy from concept through commercialization. You will serve as a subject matter expert in automation, process development, and validation in regulated environments, while mentoring engineering teams and influencing cross-functional decision-making.</p> <p>What You Will Do</p> <p>Lead the design and development of manufacturing processes, production layouts, and automation systems for medical device assemblies. Architect and implement end-to-end automation systems including robotics, vision systems, and SCADA platforms from concept through commissioning (FAT/SAT) Drive scale-up from manual assembly to high-speed, semi-automated or "lights-out" production environments Oversee process validation activities including Test Plans, Validation Plans, and IQ/OQ/PQ execution Ensure compliance with GMP, ISO 13485, and GxP standards, including documentation such as PFMEAs. Analyze and optimize manufacturing processes for yield, throughput, cost reduction, and quality improvements Resolve complex technical challenges across manufacturing operations using advanced engineering judgment Provide strategic guidance to product design teams to ensure manufacturability and scalability Lead and mentor engineering teams; provide technical oversight, coaching, and performance feedback Collaborate cross-functionally with R&D, Quality, Supply Chain, and external partners to drive program success Contribute to business development initiatives and support client engagements as a technical leader</p> <p>Required Qualifications</p> <p>Bachelor's degree in mechanical, Manufacturing, Electrical, or related Engineering discipline 7-10+ years of experience in medical device, pharmaceutical, or regulated high-volume manufacturing environments Deep expertise in automation technologies (robotics, PLCs, machine vision, motion control systems) Proven experience designing and scaling automated manufacturing lines Strong knowledge of process validation, GMP, ISO 13485, and regulatory compliance Advanced proficiency in process development, DOE, and process capability analysis Demonstrated ability to solve complex technical problems and lead large-scale initiatives Excellent communication and leadership skills, with experience mentoring engineers and influencing stakeholders Ability to manage multiple projects and priorities in a fast-paced environment On-site work environment in Providence, RI</p> <p>Preferred Qualifications</p> <p>Master's or PhD in Engineering or related discipline Experience implementing "lights-out" or highly automated manufacturing environments Expertise with CAD tools and manufacturing simulation software Experience working with contract manufacturers and automation vendors Background in disposable medical devices, diagnostics, or drug delivery systems Familiarity with Computer System Validation (CSV) and digital manufacturing systems</p> <p>Location</p> <p>This is an onsite opportunity with hybrid capabilities in Providence, RI</p>