Process Engineer II/ Sr, Technology Development

JOB DESCRIPTION

Process Engineer II / Sr, Technology Development

REPORTS TO: Vice President, Technology Development 

STATUS: Full-Time (onsite)

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

POSITION SUMMARY:

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.

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.

ESSENTIAL DUTIES:

• 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.
• Lead transfer of new processes from R&D to manufacturing, including process characterization, risk assessment (pFMEA), pilot builds, and validation (IQ/OQ/PQ).
• Partner with R&D to apply design for manufacturing (DFM) principles, identifying yield, cost, and scalability risks before designs are frozen.
• Characterization of polymer and thin-film coating processes (e.g., spin coating, polymer curing, surface activation and modification) on wafer-level runs.
• Own assigned manufacturing processes, monitoring yield, cycle time, and defect rates, and driving root cause analysis and corrective action (CAPA) when issues arise.
• Design and analyze experiments (DOE) to define process windows and improve robustness.
• Establish statistical process control (SPC) and capability studies (Cpk) for critical process parameters.
• Write incoming material specifications and acceptance criteria for polymers, monomers, reagents, wafers, and consumables, including sampling plans and test methods.
• Qualify new materials and suppliers; manage change notifications and second-source qualification.
• Work with procurement and suppliers on material availability, lot-to-lot variability, and supply risk.
• Write and maintain clear work instructions, SOPs, process flow diagrams, and travelers that operators can follow without engineering support.
• Train manufacturing staff on new and changed processes.
• Author protocols and reports for validations, material qualifications, and engineering studies under document control.
• Analyze process and test data in JMP (or equivalent) to make data-driven decisions and communicate them to cross-functional teams.
• Query and maintain manufacturing and lab data in SQL databases to track lots, product functionality, and process trends.

EDUCATION/EXPERIENCE/SKILLS:

• BS or MS in Chemical Engineering, Materials Science, Polymer Science, Chemistry, Bioengineering, or a related field.
• 5–7 years of industry experience in process engineering, manufacturing engineering, or a similar role in biotech, medical devices, diagnostics, or semiconductors.
• Experience working under a quality system (ISO 13485)
• Working knowledge of polymer chemistry and materials, such as polymerization and curing, coatings and thin films, surface treatment, spin-coating wafers and material characterization.
• Experience with semiconductor or microfabrication processes (e.g., photolithography, deposition, etching, wafer handling, cleanroom practice).
• Background in microfluidics or lab-on-chip devices
• Demonstrated experience writing incoming material specifications and acceptance criteria, and working with suppliers on material quality.
• Track record of writing clear, usable work instructions and SOPs.
• Hands-on experience transferring processes from development to manufacturing.
• Applied knowledge of design for manufacturing (DFM) and process risk tools such as pFMEA.
• Proficiency in JMP or similar statistical software (Minitab, R, Python) for DOE, SPC, and capability analysis.
• Ability to write SQL queries to pull, join, and summarize data from relational databases.
• Clear written and verbal communication across scientists, engineers, and operators.