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)

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.

BioPharma Consulting JAD Group

New Jobs

Manufacturing Engineer Contractor