Sr Principal Manufacturing Engineer

About the role

The Senior Principal Manufacturing Engineer at Veranex is a technical leader responsible for designing, scaling, and optimizing advanced manufacturing systems for medical devices, with a focus on high-volume automation.

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.

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.
• Able to manage multiple projects and priorities in a fast-paced environment.

Qualifications

• Master’s or PhD in Engineering or related discipline preferred.
• 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.

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.

Benefits

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

Pay

Negotiable based on experience and qualifications.

Schedule

Full-time, Monday-Friday, with occasional travel.