GenMark 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: 

1. Using Computational Fluid Dynamics (CFD) or flow-simulation software to model nanoliter or microliter-scale fluid dispensing processes.

2. Developing, characterizing, or validating automated manufacturing vision systems or optical inspection hardware for defect detection.

3. Designing or characterizing surface treatment processes (including plasma cleaning or chemical vapor deposition) using surface analysis techniques to ensure robust material adhesion.

4. Applying Design for Six Sigma (DFSS) methodologies and utilizing statistical software (JMP or Minitab) to strategize and perform Design of Experiments (DoE) and process capability analysis.

5. Leading design transfer of electromechanical and microfluidic devices, including strategizing and generating IQ/OQ/PQ protocols compliant with ISO 13485 and FDA 21 CFR Part 820.

6. Performing complex root cause analysis on manufacturing non-conformances by correlating production data with theoretical engineering models (thermal, fluidic, or optical).

May telecommute up to 1 day per week.

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Worksite: 2210 Faraday Ave, Suite 120, Carlsbad CA, 92008 

The expected annual salary range for this position based on the primary location for this position of Carlsbad, California is $157,056 to $169,000 per year.  Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash )