Process Engineer II/ Sr, Technology Development in San Diego

Job Description

JOB DESCRIPTION

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Process Engineer II / Sr, Technology Development

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REPORTS TO: Vice President, Technology Development 

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STATUS: Full-Time (onsite)

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SALARY RANGE: $100,000 - $130,000

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POSITION SUMMARY:

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We are hiring a Process Engineer to take microfluidic devices from the R&D bench into reliable, scalable manufacturing. Our platform combines semiconductor processing with biological sample processing, and this role sits at that intersection.

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You will own processes end to end: defining incoming material specifications, writing the work instructions operators follow, transferring new processes from R&D to production, and using data to keep them in control. You will work closely with R&D scientists, manufacturing operators, quality, and suppliers.

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ESSENTIAL DUTIES:

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• Work with scientists and engineers to develop new processes within the R&D setting. Requiring a multi-disciplinary approach to materials, polymers, and semi-conductors.  

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• Lead transfer of new processes from R&D to manufacturing, including process characterization, risk assessment (pFMEA), pilot builds, and validation (IQ/OQ/PQ).

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• Partner with R&D to apply design for manufacturing (DFM) principles, identifying yield, cost, and scalability risks before designs are frozen.

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• Characterization of polymer and thin-film coating processes (e.g., spin coating, polymer curing, surface activation and modification) on wafer-level runs.

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• Own assigned manufacturing processes, monitoring yield, cycle time, and defect rates, and driving root cause analysis and corrective action (CAPA) when issues arise.

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• Design and analyze experiments (DOE) to define process windows and improve robustness.

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• Establish statistical process control (SPC) and capability studies (Cpk) for critical process parameters.

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• Write incoming material specifications and acceptance criteria for polymers, monomers, reagents, wafers, and consumables, including sampling plans and test methods.

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• Qualify new materials and suppliers; manage change notifications and second-source qualification.

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• Work with procurement and suppliers on material availability, lot-to-lot variability, and supply risk.

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• Write and maintain clear work instructions, SOPs, process flow diagrams, and travelers that operators can follow without engineering support.

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• Train manufacturing staff on new and changed processes.

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• Author protocols and reports for validations, material qualifications, and engineering studies under document control.

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• Analyze process and test data in JMP (or equivalent) to make data-driven decisions and communicate them to cross-functional teams.

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• Query and maintain manufacturing and lab data in SQL databases to track lots, product functionality, and process trends.

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EDUCATION/EXPERIENCE/SKILLS:

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• BS or MS in Chemical Engineering, Materials Science, Polymer Science, Chemistry, Bioengineering, or a related field.

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• 5–7 years of industry experience in process engineering, manufacturing engineering, or a similar role in biotech, medical devices, diagnostics, or semiconductors.

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• Experience working under a quality system (ISO 13485)

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• Working knowledge of polymer chemistry and materials, such as polymerization and curing, coatings and thin films, surface treatment, spin-coating wafers and material characterization.

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• Experience with semiconductor or microfabrication processes (e.g., photolithography, deposition, etching, wafer handling, cleanroom practice).

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• Background in microfluidics or lab-on-chip devices

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• Demonstrated experience writing incoming material specifications and acceptance criteria, and working with suppliers on material quality.

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• Track record of writing clear, usable work instructions and SOPs.

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• Hands-on experience transferring processes from development to manufacturing.

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• Applied knowledge of design for manufacturing (DFM) and process risk tools such as pFMEA.

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• Proficiency in JMP or similar statistical software (Minitab, R, Python) for DOE, SPC, and capability analysis.

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• Ability to write SQL queries to pull, join, and summarize data from relational databases.

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• Clear written and verbal communication across scientists, engineers, and operators.

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