Medical Device Consulting: R&D Engineering | Manufacturing Engineering | RAQA
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Guiding Innovation, Ensuring Success
We help medical device companies get work and projects done faster, smarter, and fully compliant. 
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Who we are and what we do

At Square-1 Engineering, we envision a world where medical technology empowers every person to live fearlessly. We’re dedicated to driving innovation that changes lives for the better. By advancing solutions that improve patient outcomes today, we’re working toward a future free from disease and medical disorders—so that one day, we can all live fearlessly.

These guiding principles influence everything we do:
  • Continuous Self-Improvement: We are always learning, growing, and adapting.
  • A "Leave Them Speechless" Mentality: We aim to exceed expectations, leaving a lasting impact with every project delivered.
  • Reputation Over Profits: We prioritize integrity above all else, earning a reputation for honesty, reliability, and excellence in everything we do.
  • Esprit de Corps: We work as one team—supporting, collaborating, and celebrating each other’s strengths.
  • Enjoying What We Do: We bring enthusiasm to every challenge, embracing the journey and having fun along the way.
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SQR1 Beginnings

Square-1 Engineering (SQR1) started in 2016—just one person, one service, and a rented bedroom as headquarters.  We were born out of an industry necessity; in fact, our customers helped to create us!  

Many medical device OEMs in southern California were fed up with the way consulting services were operating. They were starved for good technical project support which understood the nuances of the startup and mid-size OEM world.  Square-1 got its start solving engineering and compliance problems for ‘the little guys', the startups who were often overlooked by the big consulting firms. 

Today our team of over 40 teammates offers a full suite of services to medical device companies of all sizes from phase-0 startups to the biggest strategics.  
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What sets us apart

We’ve grown to support global companies while staying true to our core—delivering quality results and a world-class customer experience. Our guiding principle? Leave Them Speechless.
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With over a decade of specialized expertise in R&D, Quality & Compliance, Regulatory (RAQA), and Manufacturing Engineering, we know the unique challenges of medical device development. That’s why we’ve built a flexible, cost-effective service model—one that trims the inefficiencies of larger firms and delivers solutions tailored to your needs.
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Let's continue the conversation

Set up a call to find the right solution for you.
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Check out our founder's interview on 'Beyond'

Giving Back

SQR-1 is proud to support local non-profits

Device Alliance
​We're platinum corporate sponsors of DeviceAlliance - Southern California's only non-profit professional association serving the medical device industr
y.
 
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T’ena Health
T’ena Health is a nonprofit organization that provides health disparities through resources, knowledge, and compassion to marginalized communities. We are honored to serve our community. 
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Second Harvest Food Bank
Square-1 is an active supporter of the Second Harvest Food Bank, the largest nonprofit hunger relief organization leading the fight to end hunger in the Orange County, CA community.
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White Papers &​ Articles

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The History of Southern California Medical Device
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  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
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      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us
  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
      • Manufacturing Engineering
      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us