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.

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 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

Required Qualifications

• 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

Preferred Qualifications

• 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

Location

• This is an onsite opportunity with hybrid capabilities in Providence, RI