Senior Manufacturing & Quality Engineer

Senior Manufacturing & Quality Engineer Miami Lakes, FL | Full-Time | Onsite The Opportunity If you've spent your career doing the actual work — not managing people who do it — this role was built for you. We're a boutique medical device contract development and manufacturing organization (CDMO) in Miami Lakes specializing in complex cardiovascular and electromechanical systems. We work with innovative, growth-stage MedTech companies that are building technologies that matter. Our team is small, our standards are high, and the work is genuinely interesting. We're looking for a Senior Manufacturing & Quality Engineer who can own both sides of the equation — someone who writes the work instruction in the morning, troubleshoots a nonconformance in the afternoon, and designs a SolidWorks fixture before the day is done. If that sounds like your normal Tuesday, keep reading. What You'll Own Product Development Lead and support product development activities with full design control compliance Develop and execute Design Verification and Validation (DVP&R) protocols Review engineering drawings for tolerancing, manufacturability, and inspection feasibility Conduct tolerance stack-up analysis and risk assessments Author risk documentation including dFMEA, uFMEA, and pFMEA Manufacturing Engineering & Process Development Design, develop, and optimize manufacturing processes using Lean, Six Sigma, and DFM principles Lead continuous improvement initiatives to enhance yield, reduce scrap, and drive efficiency Design and implement tooling, fixtures, and test equipment for production and validation Develop and maintain assembly procedures, work instructions, and BOM updates Troubleshoot production issues and implement real, sustainable corrective actions Author and execute Equipment and Process Validations (IQ/OQ/PQ) Quality Engineering & Compliance Develop and maintain inspection methods, quality control plans, and statistical techniques including MSA and inspection method validation Lead nonconformance investigations, CAPA, deviations, and complaint handling using root cause analysis Ensure compliance with

FDA QMSR, ISO

13485, and

ISO 14971

Support internal and external audits and regulatory inspections Develop and validate test methods and tooling for component and assembly inspection Cross-Functional Leadership Serve as the technical bridge between Engineering, Quality, Operations, and Supply Chain Collaborate with suppliers to improve quality and support supplier qualification Train and mentor junior engineers and quality inspectors Drive a culture of quality, accountability, and continuous improvement Documentation & Systems Maintain engineering documentation in EPDM and Greenlight Guru Generate technical reports, validation documentation, and test protocols Ensure proper document control and traceability Additional Design CAD models, tooling, and test fixtures using SolidWorks Support field service activities as needed What You Bring Bachelor's degree in Mechanical, Biomedical, or related Engineering field 8+ years of experience in manufacturing and/or quality engineering — medical device strongly preferred Proven depth in design controls, IQ/OQ/PQ process validation, CAPA, and root cause analysis Strong experience in inspection methods, metrology, and measurement system validation Lean manufacturing and/or Six Sigma background SolidWorks proficiency — specifically tooling, fixtures, and manufacturing jigs Working knowledge of

FDA QMSR, ISO

13485, and

ISO 14971

Fluent in English; Spanish proficiency is a meaningful plus Self-starter mentality — you figure things out, you don't wait to be told Who Thrives Here This is not a role for someone looking to manage from a distance or hand off the hard stuff. It's for someone who genuinely enjoys being in the details, solving real problems, and building things that work. You'll have direct access to leadership, real ownership of your domain, and the satisfaction of seeing your work impact products that reach patients. If you've come from a large company and felt buried in bureaucracy — or if you've always thrived in lean, fast-moving environments — this is the kind of place where strong engineers do some of their best work. Reports To Senior Engineering Manager Location Miami Lakes, FL —

Onsite Pay:

$130,000.00 - $160,000.00 per year

Benefits:

401(k) Dental insurance Flexible schedule Parental leave Retirement plan

Work Location:

In person