About This RoleThe 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. What You Will Do 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 environmentsOversee process validation activities including Test Plans, Validation Plans, and IQ/OQ/PQ executionEnsure 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 improvementsResolve complex technical challenges across manufacturing operations using advanced engineering judgmentProvide strategic guidance to product design teams to ensure manufacturability and scalabilityLead and mentor engineering teams; provide technical oversight, coaching, and performance feedbackCollaborate cross-functionally with R&D, Quality, Supply Chain, and external partners to drive program successContribute to business development initiatives and support client engagements as a technical leader Required Qualifications Bachelor’s degree in mechanical, Manufacturing, Electrical, or related Engineering discipline7–10+ years of experience in medical device, pharmaceutical, or regulated high-volume manufacturing environmentsDeep expertise in automation technologies (robotics, PLCs, machine vision, motion control systems)Proven experience designing and scaling automated manufacturing linesStrong knowledge of process validation, GMP, ISO 13485, and regulatory complianceAdvanced proficiency in process development, DOE, and process capability analysisDemonstrated ability to solve complex technical problems and lead large-scale initiativesExcellent communication and leadership skills, with experience mentoring engineers and influencing stakeholdersAbility to manage multiple projects and priorities in a fast-paced environmentOn-site work environment in Providence, RI Preferred Qualifications Master’s or PhD in Engineering or related disciplineExperience implementing “lights-out” or highly automated manufacturing environmentsExpertise with CAD tools and manufacturing simulation softwareExperience working with contract manufacturers and automation vendorsBackground in disposable medical devices, diagnostics, or drug delivery systemsFamiliarity with Computer System Validation (CSV) and digital manufacturing systems Location This is an onsite opportunity with hybrid capabilities in Providence, RI