Process Development Engineer

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Gen Mark Diagnostics, Inc. seeks a Staff Process Development Engineer at its Carlsbad, CA location.

Duties:
Drive stable and reliable production for new manufacturing processes recently transferred to production. Develop and characterize manufacturing processes, including surface treatment (i.e., plasma, CO2 cleaning) and precision dispensing of fluids and adhesives. Create and maintain process input and output specifications, performing capacity analyses, troubleshooting, testing, and providing support for existing products and new product lines. Drive process development, characterization and improvement activities to both new and existing product lines.

Lead project teams as part of product improvements, automation, and quality improvements. Apply statistical methods to various production performance datasets to monitor, track and trend, and/or assess opportunities for improvement in capacity, yield, and/or utilization. Troubleshoot and investigate issues that arise within the manufacturing process and communicate findings. Perform complex root cause analysis on manufacturing non-conformances by correlating production data with theoretical engineering models (chemical, thermal, fluidic, and optical) to implement sustainable countermeasures for issues in micro-fabrication and device assembly.

Develop and characterize precision nanoliter-scale dispensing processes for reagents and adhesives by applying Computational Fluid Dynamics (CFD) and flow-simulation modeling to predict fluid behavior and optimize deposition accuracy in high-throughput manufacturing environments. Design and validate surface treatment processes, specifically plasma and carbon dioxide (CO2) cleaning, by utilizing surface analysis data (such as contact angle measurements or Scanning Electron Microscopy) to ensure robust adhesion for laser bonding and micro-assembly applications.

Develop and qualify automated manufacturing vision systems for defect detection, utilizing applied knowledge of optics fundamentals, image processing algorithms, and hardware limitations to ensure 100% in-line quality inspection of medical device assemblies. Drive process stability and capability improvements by applying Design for Six Sigma (DFSS) methodologies and advanced statistical analysis (including Design of Experiments, Gauge R&R) using software such as JMP or Minitab to model process windows for critical-to-quality (CTQ) parameters.

Lead the design transfer of complex electromechanical and microfluidic devices from R&D to production, including the generation of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols that comply with ISO 13485 and FDA 21 CFR Part 820 regulatory standards. May telecommute up to 1 day per week.

Education and Experience Requirement:
Requires a Bachelor’s degree, or foreign equivalent, in Engineering or related field and 8 years of progressive, post-baccalaureate experience as an Engineer in the or related position in the pharmaceutical, biotechnology or medical industry.

Specials Skills Requirement: 2 years of experience must include: