Title: Sr. Manufacturing & Quality Engineer Location: Miami, FL Industry: Medical Device -Engineering/Operations/Quality Schedule: Monday-Friday, 8am-5pm Employment Type: Direct hire Salary: Up to $130k with great benefits (health benefits 100% paid for)
Company Overview: Join a dynamic and growing organization at the forefront of medical device manufacturing, where engineering excellence meets patient impact. In this highly visible role, you ll own both manufacturing and quality engineering initiatives playing a critical part in bringing innovative products to market while ensuring the highest standards of compliance and performance.
Position Overview: As a Senior Manufacturing & Quality Engineer, you ll serve as a key technical leader across product development, manufacturing, and quality systems. You ll drive process optimization, lead validation efforts, and partner cross-functionally to ensure products are safe, effective, and scalable.
Responsibilities: Product Development & Design Control
Lead and support product development activities in compliance with design control requirements
Develop and execute Design Verification & Validation (DV&V) protocols
Review engineering drawings for tolerancing, manufacturability, and inspection readiness
Perform tolerance stack-ups and risk assessments to ensure robust designs
Author and maintain risk management documentation (dFMEA, pFMEA, uFMEA)
Support regulatory submissions with technical expertise and documentation
Manufacturing Engineering & Process Excellence
Design, develop, and optimize manufacturing processes using Lean, Six Sigma, and DFM principles
Lead continuous improvement initiatives to increase yield, reduce scrap, and improve throughput
Design and implement tooling, fixtures, and test equipment
Develop and maintain work instructions, assembly procedures, and BOMs
Troubleshoot production challenges and implement sustainable solutions
Lead process and equipment validations (IQ/OQ/PQ)
Quality Engineering & Compliance
Develop inspection methods, control plans, and statistical techniques (MSA, validation methods)
Lead investigations (nonconformances, CAPAs, deviations, complaints) using root cause analysis, technical writing
Ensure compliance with FDA QMSR, ISO 13485, and ISO 14971
Support internal/external audits and regulatory inspections
Develop and validate test methods and inspection tooling
Leadership & Cross-Functional Collaboration
Act as a technical bridge across Engineering, Quality, Operations, and Supply Chain
Partner with suppliers to improve quality and support qualification efforts
Mentor junior engineers and inspectors, fostering a high-performance culture
Champion continuous improvement, accountability, and quality excellence
Documentation & Systems
Maintain engineering documentation in systems such as EPDM and Greenlight Guru
Generate validation protocols, technical reports, and test documentation
Ensure strong document control and traceability
Qualifications
Bachelor s degree in Mechanical, Biomedical, or related Engineering field
8+ years of experience in manufacturing and/or quality engineering within class I and/or II medical device
Proficiency in CAD (SolidWorks preferred)
Strong communication and problem-solving skills
Bi-lingual, English and Spanish language skills
Independent, self-starter and capable of solving problems
Strong expertise in:
Design controls & product development
Process validation (IQ/OQ/PQ)
CAPA, root cause analysis, and quality systems
Inspection methods, metrology, and MSA
Lean Manufacturing and/or Six Sigma
Why Join?
High-impact role with visibility across the organization
Opportunity to influence both product development and manufacturing strategy
Collaborative, cross-functional environment
Strong growth potential within a regulated, innovation-driven industry
Competitive compensation and benefits
EOE/ADA IND123
SRG4 Life Sciences delivers flexible staffing solutions nationwide, specializing in pharmaceutical, CDMO/CMO, medical device, clinical research, PBM, pharmacy, food and beverage, nutraceutical, laboratory, and consumer product sectors. We provide contract, contract-to-hire, and direct hire placements across a wide range of critical roles including Scientists, Formulators, Engineers, QA/Regulatory Affairs, Microbiologists, Manufacturing Technicians, Supply Chain/Procurement Specialists, Project Managers, and Business Development professionals. SRG4 Life Sciences operates on a relationship-driven model partnering closely with clients to understand not only the role, but the company s culture, goals, and vision. Our mission is to match purpose-driven professionals with organizations committed to advancing human health, building long-term partnerships that drive innovation, quality, and performance.