Senior Staff Manufacturing Process Engineer

Cellanome•Foster City, CA

1d•Onsite

About The Position

We are looking for a Senior Staff Manufacturing Process Engineer to join our team. This role will play a critical part in scaling and maturing manufacturing for the key consumable components of our novel life science instrument platform. The Sr. Staff Manufacturing Process Engineer will oversee the consumable life cycle management (LCM) - from New Product Introduction (NPI) to drive continuous improvement across Manufacturing and lead sustaining engineering for released consumable products — while representing Operations on cross-functional teams throughout the product lifecycle.

Requirements

Bachelor's degree in Mechanical, Chemical, Biochemical, Materials Science, or related Engineering discipline; advanced degree preferred.
Typically requires 12 years of progressive experience in manufacturing/process engineering, spanning NPI, continuous improvement and sustaining engineering within a consumables, medical device, or life sciences manufacturing environment.
Demonstrated experience leading new product introductions from development through full-scale production launch.
Strong hands-on experience in cleanroom and/or ISO/cGMP manufacturing environments.
Proficient in process validation methodologies (IQ/OQ/PQ), FMEA, root cause analysis, and CAPA processes.
Working knowledge of statistical tools (SPC, DOE, Minitab/JMP or similar) for process characterization and improvement.
Proficient in utilizing AI tools to conduct experimental design, data analysis, build MFG KPI & SPC charting and monitoring systems.
Excellent cross-functional communication and project management skills, with a proven ability to represent Operations on cross-functional teams and influence technical and business decisions.
Ability to author, review, and maintain technical documentation (SOPs, protocols, work instructions, batch records).
Demonstrated ability to perform the Essential Duties of the position with or without reasonable accommodations.

Nice To Haves

Experience with flow cell, microfluidics, reagents, or other single-cell/genomics consumable manufacturing.
Lean/Six Sigma Green Belt or Black Belt certification.
Project Management (PMP) certification.
Experience with manufacturing automation implementation and scale up.
Experience with MFG ERP, MES, PLM, and web-based batch record systems.
Prior experience in a fast-paced start-up environment, comfortable wearing multiple hats.

Responsibilities

Lead new process transfer and qualification of new consumable manufacturing processes, transitioning products from R&D & pilot scale into full-scale production.
Represent Consumable LCM on cross-functional teams throughout the product development lifecycle, providing manufacturability, process, and operational input into design and business decisions.
Own sustaining engineering support for released consumable products, including troubleshooting, root cause analysis (5-Why, fishbone, 8D) and implementation of corrective and preventive actions (CAPA).
Investigate and resolve non-conformances and deviations.
Identify, prioritize, and lead continuous improvement projects to improve yield, cycle time, capacity, and COGs across consumable manufacturing lines.
Partner with Product Development Team to develop a variety of tech transfer deliverables, including product BOM, manufacturing process design, pFMEA, control plan, equipment sourcing & onboarding and process work instructions.
Partner with the broader Operation Team to complete operational readiness for new consumable products, including batch records, space control, labeling & packaging, supply chain readiness, MFG capacity & capability and staff training.
Develop and optimize process performance monitoring system and apply Lean Manufacturing, Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE) methodologies to optimize processes and reduce variations.