Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we…
Skills: Automation Systems, Robotics, Process Validation, ISO 13485, GMP
Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we…
Skills: 3D CAD, 2D CAD, Rapid Prototyping, Electro-mechanical Design, Medical Device Development
Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we…
Skills: Circuit Design, Digital Interfaces, Rapid Prototyping, Simulation, Debugging
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$139k–$198k/yr
Full-time
bachelor degree, postgraduate degree
Posted 5d ago
~40 hrs/week
Responsibilities
Lead the design, scaling, and optimization of advanced automated manufacturing systems for medical devices from concept to commercialization. Provide technical oversight and mentorship to engineering teams while ensuring compliance with regulatory standards like GMP and ISO 13485.
Requirements
Requires a Bachelor's degree in Engineering and 7-10+ years of experience in regulated high-volume manufacturing environments. Must possess deep expertise in automation technologies, process validation, and the ability to lead large-scale technical initiatives.
Full job description
Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take 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.
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
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.
Veranex is the world's first global Innovation Contract Research Organization (iCRO) providing integrated product development and contract research services for medical device and in-vitro diagnostic companies.
Founded in 2021 but with a legacy over 20 years, Veranex combines design engineering, preclinical research, clinical trials, regulatory affairs, quality consulting, manufacturing, and market access services under one roof. This integrated approach eliminates traditional handoffs between development phases, reducing timelines and budget variance for clients.
The company serves medical device innovators from early-stage startups to global strategics across cardiovascular, neurovascular, ophthalmology, and diagnostic markets. With more than 800 specialists across North America, Europe, and Asia-Pacific, Veranex has supported over 1,000 device programs and 2,500 clinical trials (preclinical-feasibility and pivotal).
Headquartered in Raleigh, North Carolina, Veranex operates facilities in the US, Europe and Asia-Pacific with 15+ innovation and research centers.
For more information, visit https://veranex.com/
Offices: 5420 Wade Park Blvd, Suite 204, Raleigh, North Carolina 27607, US · 55 Dupont Dr, Providence, Rhode Island 02907, US · 1414 Marshall St NE, Minneapolis, Minnesota 55413, US · 7 Lenora St, Worcester, Massachusetts 01607, US · Atlanta, Georgia, US
Veranex is the world's first global Innovation Contract Research Organization (iCRO) providing integrated product development and contract research services for medical device and in-vitro diagnostic companies.
Founded in 2021 but with a legacy over 20 years, Veranex combines design engineering, preclinical research, clinical trials, regulatory affairs, quality consulting, manufacturing, and market access services under one roof. This integrated approach eliminates traditional handoffs between development phases, reducing timelines and budget variance for clients.
The company serves medical device innovators from early-stage startups to global strategics across cardiovascular, neurovascular, ophthalmology, and diagnostic markets. With more than 800 specialists across North America, Europe, and Asia-Pacific, Veranex has supported over 1,000 device programs and 2,500 clinical trials (preclinical-feasibility and pivotal).
Headquartered in Raleigh, North Carolina, Veranex operates facilities in the US, Europe and Asia-Pacific with 15+ innovation and research centers.
For more information, visit https://veranex.com/
Offices: 5420 Wade Park Blvd, Suite 204, Raleigh, North Carolina 27607, US · 55 Dupont Dr, Providence, Rhode Island 02907, US · 1414 Marshall St NE, Minneapolis, Minnesota 55413, US · 7 Lenora St, Worcester, Massachusetts 01607, US · Atlanta, Georgia, US