Sr. Manufacturing and Quality Engineer

Senior 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 (health benefits 100% paid for)

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.

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.

• 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

• 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)

• 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

• 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

• 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

• 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 (Solid Works 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

• 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