Manufacturing Engineer

Yochana

Orlando (FL)

On-site

USD 75,000 - 90,000

Full time

14 days+

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Job summary

A medical device manufacturing company based in Orlando, Florida, is seeking a Manufacturing Engineer. The candidate will be responsible for protocol reviews, process audits, and design of experiments to ensure compliance with industry standards. Qualifications include a Bachelor’s or Master’s degree and over 5 years of relevant experience, particularly in medical device manufacturing. The role is contract-based at the mid-senior level with competitive compensation ranging from $75,000 to $90,000.

Qualifications

5+ years of experience in medical device manufacturing.
Strong understanding of FDA, ISO 13485, and GMP requirements.
Excellent analytical, problem-solving, and communication skills.

Responsibilities

Conduct audits of manufacturing processes and document gaps.
Implement process optimization using Design of Experiments (DoE).
Monitor validated process parameters for compliance.

Skills

CNC Machining

Problem-solving

Statistical Analysis

Quality Management Systems (QMS)

Collaboration with cross-functional teams

Medical device manufacturing

Education

Bachelor’s or Master’s degree in Mechanical Engineering or related field

Tools

Minitab

JMP

Job description

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Human Resource Specialist @ Yochana IT Solutions INC | Problem Solving

Job Title: Manufacturing Engineer

Job Description & Skill Requirement

Protocol Review & Compliance: Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.
Process Audits & Documentation: Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.
Process Optimization: Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM. Establish and document robust process parameters and operating windows.
Validation Execution: Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ, OQ, PQ reports based on validation activities.
Statistical Analysis: Run statistical reports to analyze process capability, variability, and performance trends.
Change Management: Lead and document change management activities related to process improvements and equipment modifications.
Continuous Monitoring: Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.
Experience working in QMS and ERP systems
Experience with IQ/OQ/PQ/TMV preferred
Worked with cross functional teams
Collaborate with Quality Engineering to provide manufacturing support.
Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
Should be experienced in Medical device manufacturing assembly lines
Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
Need to conduct qualification, verification, and validation activities to produce medical devices.
Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.
Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
Work with CFT teams in troubleshooting problems on the production floor.

Qualification:

Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
5+ years of experience in medical device manufacturing, with hands-on experience in CNC Machining and DCM.
Strong understanding of FDA, ISO 13485, and GMP requirements.
Proficiency in statistical analysis tools (e.g., Minitab, JMP).
Experience with QMS systems and documentation practices.
Excellent analytical, problem-solving, and communication skills.

Thanks & Regards,

Resource Specialist

Yochana Solutions Inc

Seniority level