Job Description
This
Senior Manufacturing & Quality Engineer opportunity at BIOREP Technologies puts you in ownership of both manufacturing and quality engineering functions at a specialized medical device CDMO in Miami Lakes - no silos, no bureaucracy, just real technical ownership across the full product lifecycle. You'll be embedded in complex cardiovascular and electromechanical device development, working directly alongside leadership on new and growing product partnerships. If you're a hands-on engineer who thrives in a fast-moving environment and wants to build something meaningful, this is the role for you.
Minimum Requirements
EDUCATION- Bachelor's degree in Mechanical, Biomedical or related Engineering field.
EXPERIENCE- 5+ years of experience in manufacturing and/or quality engineering (medical device preferred)
- Strong experience with:
- Design controls & product development
- Process validation (IQ/OQ/PQ)
- CAPA and root cause analysis
- Strong experience in inspection methods, metrology, and measurement system validation
- Lean manufacturing / Six Sigma
Job Requirements
Product Development- Lead and participate in product development activities ensuring compliance with design control requirements
- Develop and execute Design Verification and Validation protocols
- Review engineering drawings for tolerancing, manufacturability, and inspection feasibility
- Support regulatory submissions with technical documentation and engineering expertise
- Conduct complex tolerance stack-up analysis and risk assessments
- Author Risk Documentation (dFMEA, uFMEA, 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 improve 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 sustainable corrective actions
- Author and conduct Equipment and Process Validations (IQ/OQ/PQ)
Quality Engineering & Compliance- Develop and maintain inspection methods, quality control plans, and statistical techniques including measurement system analysis and validation of inspection methods
- Lead nonconformance investigations, CAPA, deviations and complaint handling using root cause analysis
- Ensure compliance with FDA QMSR, ISO 13485, and ISO 14971 requirements
- Support internal and external audits and regulatory inspections
- Assist in equipment and process validation (IQ/OQ/PQ)
- Develop and Validation Test Methods and tooling for the test and inspection of components and assembles
Cross-Functional Leadership- Serve as a technical bridge between Engineering, Quality, Operations, and Supply Chain
- Collaborate with suppliers to improve quality and support supplier qualification activities
- Train and mentor junior engineers and quality inspectors
- Drive a culture of quality, accountability, and continuous improvement
Documentation & Systems- Maintain accurate engineering documentation in systems such as EPDM and Greenlight Guru
- Generate technical reports, validation documentation, and test protocols
- Ensure proper document control and traceability
Other Responsibilities- Design CAD models, tooling, and test fixtures using SolidWorks
- Support field service activities
Compensation Information
- Base salary: Flexible to overall experience; annual bonus potential based on company performance
- 401(k)
- Healthcare
- HSA
- Vision & Dental
- Paid Time Off
Location
- Territory Parameters: Miami Lakes, FL (HQ Location); On-site with some remote work as desired
