Sr Principal Manufacturing Engineer

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

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.

• 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

• 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

• 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

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

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.