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.
