Process Development Engineer — Precision Biotech

Roche; Carlsbad (NM); Hybride; USD 157 000 - 169 000; Plein temps

Avantages offerts par ce poste

Discretionary annual bonus

Benefits package

Résumé du poste

GenMark Diagnostics, Inc. in Carlsbad, CA, now part of Roche, is seeking a Staff Process Development Engineer to lead advanced manufacturing process development for micro- and nano-scale fluid handling and surface treatments.

You will drive new processes, characterize performance, and scale transfer to production with ISO 13485 and FDA alignment. The role requires a Bachelor's in Engineering and 8 years of related experience in pharma/biotech, with expertise in CFD, DFSS/DoE, automated vision

Qualifications

• Requires a bachelor’s degree in Engineering or related field.
• 8 years of progressive, post-baccalaureate experience as an Engineer in pharma/biotech or related field.
• Experience with CFD/flow-simulation tools.
• Experience with automated manufacturing vision systems for defect detection.
• Knowledge of surface treatment processes (plasma cleaning or CVD).
• Experience applying DFSS and DoE with statistical software (JMP, Minitab).

Responsabilités

• Drive stable and reliable production for new manufacturing processes.
• Develop and characterize manufacturing processes including surface treatment and precision dispensing.
• Create and maintain process specifications, perform capacity analyses, troubleshoot, and support existing products.
• Lead project teams on product improvements, automation, and quality improvements.
• Apply statistical methods to production performance datasets to monitor capacity, yield, and utilization.
• Lead design transfer of complex devices from R&D to production with IQ/OQ/PQ protocols (ISO 13485 & FDA 21 CFR Part 820).
• Perform root-cause analysis on manufacturing non-conformances by correlating production data with engineering models.

Connaissances

CFD modeling

Flow simulation

Vision systems

Surface treatment

Design for Six Sigma

DoE

Gage R&R

Root cause analysis

Formation

Bachelor's degree in Engineering or related field

Outils

JMP

Minitab

Description du poste

GenMark Diagnostics, Inc. in Carlsbad, CA, now part of Roche, is seeking a Staff Process Development Engineer to lead advanced manufacturing process development for micro- and nano-scale fluid handling and surface treatments.

You will drive new processes, characterize performance, and scale transfer to production with ISO 13485 and FDA alignment. The role requires a Bachelor's in Engineering and 8 years of related experience in pharma/biotech, with expertise in CFD, DFSS/DoE, automated vision