Engineering Excellence for Regulated Industries
At Black Star Universal Services LLC, we pride ourselves on being a leading engineering consulting firm dedicated to providing innovative solutions for regulated industries. With a focus on medical devices, aerospace, and clean energy, our team combines extensive experience with a commitment to quality and compliance. We understand the complexities of navigating regulatory landscapes and are here to support your projects from concept to completion, ensuring that every step meets the highest standards of safety and efficiency.
Your Partner in Engineering Excellence
Core Services
Project Management
Our PMP-certified project management team ensures seamless coordination and execution, delivering projects on time and within budget while adhering to regulatory standards.
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Medical Device Engineering
We specialize in medical device engineering and validation, guiding you through the complexities of compliance and ensuring your products meet the highest industry standards.
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Manufacturing Support
From manufacturing line design to vendor qualification, our support services are tailored to optimize your production processes and enhance efficiency in regulated environments.
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Process Development
We offer process development and optimization services to streamline operations, reduce costs, and improve product quality in your manufacturing processes.
Optimize Now
R&D Program Management
Our R&D program management services help you navigate the innovation landscape, ensuring your projects align with regulatory requirements and market needs.
Innovate Today
Supply Chain Support
We provide comprehensive parts acquisition and supply chain support, ensuring you have the right materials at the right time to keep your projects moving forward.
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Meet Our Leadership Team
James Butler & Lauren Butler
At Black Star Universal Services LLC, our leadership team brings a wealth of experience and expertise to the table. With a strong focus on engineering solutions and financial operations, James and Lauren Butler are dedicated to driving our mission forward.
Our team
What Our Clients Say
Client Testimonials
Black Star Universal Services provided exceptional support during our product development phase. Their expertise in medical device engineering was invaluable, and their project management skills ensured we met all regulatory requirements on time.
The level of professionalism and expertise at Black Star Universal Services is unmatched. They guided us through complex regulatory landscapes and helped us achieve compliance without compromising on quality.
Our Project Portfolio
At Black Star Universal Services LLC, we take pride in our diverse portfolio of successful projects across various regulated industries. Our engineering solutions and project management expertise have consistently delivered exceptional results, ensuring compliance and innovation. Explore some of our highlighted projects that showcase our commitment to excellence and client satisfaction.
View Our Work
Medical Device Development
We successfully led the development of a cutting-edge medical device, overseeing the entire project lifecycle from concept to market launch. Our team ensured compliance with FDA regulations and ISO standards, resulting in a product that meets the highest quality benchmarks.
FDA-compliant device launch
Aerospace Engineering
Our collaboration with an aerospace manufacturer involved optimizing their production processes and implementing Lean Six Sigma methodologies. This project not only improved efficiency but also reduced costs significantly, demonstrating our ability to enhance operational performance.
Cost reduction and efficiency improvement
Clean Energy Solutions
We partnered with a clean energy startup to develop innovative solutions for renewable energy systems. Our project management expertise facilitated seamless coordination among stakeholders, leading to successful project execution and timely delivery.
Innovative renewable energy systems
Defense Sector Support
In the defense sector, we provided comprehensive engineering support for a critical project involving advanced technology integration. Our team's meticulous planning and execution ensured that all project milestones were met on time and within budget.
Advanced technology integration
Certifications & Credentials
At Black Star Universal Services LLC, our commitment to excellence is underscored by our robust certifications and credentials. Our team is led by professionals with PMP® certification and an MBA in Project Management, ensuring that we bring a wealth of knowledge and expertise to every project. With over a decade of global experience in medical devices and regulated manufacturing, we are well-equipped to navigate the complexities of these industries. Our proficiency in IQ/OQ/PQ, TMV, Lean Six Sigma, QMS, and ERP systems further enhances our capability to deliver high-quality engineering solutions.
2
PMP® Certified Project Managers
10+
Years of Global Experience in Medical Devices
5
Core Areas of Expertise in Project Management
3
Advanced Degrees in Project Management and Engineering
Get in Touch with Us
Have questions about our consulting services? We're here to help! Fill out the form below or reach out directly via email or phone, and our team will get back to you promptly.
