88-50100414 Staff Process Development Engineer

Roche • Carlsbad, NM

32d • $157,056 - $169,000 • Hybrid

About The Position

GenMark Diagnostics, Inc. seeks a Staff Process Development Engineer at its Carlsbad, CA location. This role is responsible for driving stable and reliable production for new manufacturing processes recently transferred to production. The engineer will develop and characterize manufacturing processes, including surface treatment (i.e., plasma, CO2 cleaning) and precision dispensing of fluids and adhesives. Key duties include creating and maintaining process input and output specifications, performing capacity analyses, troubleshooting, testing, and providing support for existing products and new product lines. The position also involves leading project teams for product improvements, automation, and quality enhancements, applying statistical methods to production data, and performing complex root cause analysis on manufacturing non-conformances. A significant part of the role includes developing and characterizing precision nanoliter-scale dispensing processes using CFD and flow-simulation modeling, designing and validating surface treatment processes, and developing automated manufacturing vision systems for defect detection. The engineer will also drive process stability and capability improvements using Design for Six Sigma (DFSS) methodologies and advanced statistical analysis, and lead the design transfer of complex devices from R&D to production, including generating IQ/OQ/PQ protocols compliant with ISO 13485 and FDA 21 CFR Part 820.

Requirements

• Bachelor’s degree, or foreign equivalent, in Engineering or related field.
• 8 years of progressive, post-baccalaureate experience as an Engineer in the or related position in the pharmaceutical, biotechnology or medical industry.
• 2 years of experience using Computational Fluid Dynamics (CFD) or flow-simulation software to model nanoliter or microliter-scale fluid dispensing processes.
• 2 years of experience developing, characterizing, or validating automated manufacturing vision systems or optical inspection hardware for defect detection.
• 2 years of experience designing or characterizing surface treatment processes (including plasma cleaning or chemical vapor deposition) using surface analysis techniques to ensure robust material adhesion.
• 2 years of experience 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.
• 2 years of experience 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.
• 2 years of experience performing complex root cause analysis on manufacturing non-conformances by correlating production data with theoretical engineering models (thermal, fluidic, or optical).

Responsibilities

• 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.
• Perform capacity analyses, troubleshooting, and testing.
• Provide 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.

Benefits

• Discretionary annual bonus may be available based on individual and Company performance.
• Benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash )

What This Job Offers

• Job Type: Full-time
• Career Level: Senior