Manufacturing Engineer Contractor

Summary:
As a Manufacturing Engineer Contractor, you’ll be at the forefront of ensuring top-notch quality and efficiency for automated and semi-automated production processes. This role focuses on the validation (IQ/OQ/PQ) of production equipment and processes, with a commitment to patient safety and product quality.

Key Responsibilities:

• Lead & Execute validation activities (IQ/OQ/PQ) for both automated and semi-automated equipment, ensuring new or revised production systems meet rigorous standards.
• Innovate & Implement manufacturing processes for ophthalmic medical devices used in essential eye surgeries.
• Optimize Production by applying Lean and Six Sigma techniques to streamline processes and improve quality.
• Ensure Process Stability through Continuous Monitoring and Statistical Process Control (SPC), keeping equipment validated and processes in control.
• Analyze Quality with ongoing statistical evaluations of Critical Quality Attributes (CpK/Process Capability) to ensure product specifications are consistently met.
• Hands-On Support for production equipment, providing expert guidance from installation to post-release.
• Design & Develop fixtures using CAD software (e.g., SolidWorks) to enhance production operations.
• Collaborate Cross-Functionally with all departments, fostering a team-oriented environment through open communication.
• Establish Standards by creating comprehensive work procedures to maintain robust and reliable manufacturing processes.

Skills & Qualifications:

• Experience with Medical Device Validation (IQ/OQ/PQ)
• Strong understanding of Statistical Process Control (SPC)
• Proficiency in Statistical Analysis (Design of Experiments, ANOVA, Gage R&R, Control Charts, Process Capability)
• Skilled in CAD Design (SolidWorks) and Technical Writing
• Public speaking abilities to communicate findings and recommendations
• Familiarity with Manufacturing Simulation Software (e.g., FlexSim)

Requirements

Education:

• M.S. in Engineering or Biomedical Engineering or
• B.S. in Engineering or Biomedical Engineering

Experience:

• Minimum of 1+ year of professional experience in a Medical Device Manufacturing Environment.