Sr Principal Manufacturing Engineer
Veranex•Providence, RI
•Hybrid
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
