Lead Engineer - Medical Devices (manufacturing exp req)

Lead Manufacturing Engineer - Process & Quality Systems

Location: Greater Miami Area, FL (near Amelia Earhart Park)

Salary: $120,000-$140,000+ (Negotiable, DOE) + Company-Based Annual Bonus

Excellent Benefits: Medical (100% paid premiums for employees, 80% for family), Dental, Vision, 401k, Life, Disability, HSA, Vacation, Holidays, Sick Time

Job Type: Full-Time; Monday-Friday

Sponsorship is not available

Lead Manufacturing Engineer - Process & Quality Systems Description

Our client is seeking a Lead Manufacturing Engineer to join their team in the Miami area. They are a small, highly capable group that manufactures their own medical devices while also supporting full product design and development. This is a hands-on role centered around quality events and manufacturing process improvement within a collaborative team. You will lead investigations, develop manufacturing and inspection procedures, and play a key role in ensuring consistent, high-quality production. You will spend about 50% of your time supporting quality initiatives, 40% on manufacturing processes, and 10% supporting product development activities. You will also act as a bridge between the Quality team (4) and Manufacturing team (5), supporting cross-functional collaboration and contributing to continuous improvement efforts If you enjoy variety in your day and working across functions rather than staying in a narrowly defined role, this could be a great fit. This opportunity offers the chance to make a meaningful impact and have greater influence within a smaller, agile team. In this environment, your ideas will be heard and put into action, something that can be harder to find in larger organizations. They also offer strong benefits for a company of this size, including 100% employer-paid premiums for employees and 80% for dependents.

Lead Manufacturing Engineer - Process & Quality Systems Responsibilities

• Design, develop, and enhance manufacturing processes
• Develop inspection methods, lead CAPA and root cause analysis, and ensure compliance
• Review engineering drawings for tolerancing, manufacturability, and inspection feasibility
• Conduct tolerance stack-up analysis and risk assessments and author FMEAs
• Develop work instructions, assembly procedures, and maintain BOMs
• Troubleshoot production issues and implement corrective actions and lead IQ/OQ/PQ
• Design and implement tooling, fixtures, and test equipment for production and validation
• Lead continuous improvement initiatives to improve yield, reduce scrap, and increase efficiency
• Support product development while ensuring compliance with design control requirements
• Develop and execute design verification and validation protocols
• Support audits, manage documentation, and design CAD models and tooling in SolidWorks

Lead Manufacturing Engineer - Process & Quality Systems Qualifications

• Bachelor’s degree in engineering
• Experience working within a highly regulated environment
• Strong experience leading investigations, including CAPA, NCRs, and root cause analysis
• Experience developing manufacturing and inspection procedures
• Exposure to validation activities (IQ/OQ/PQ), including equipment or process validation
• Able to work onsite each day required