Process Development Engineer
- Santa Clara, CA
- Permanent
- Full-time
Location: 2881 Scott Blvd., Santa Clara, CA 95050
Duration: 12-Month Contract (Potential for Extension or Permanent Conversion)
Pay Rate: $61.48 - $100.18/hr. on W2
Benefits: Paid weekly; Vision, Dental, and MedicalSummary:
Join the Client Unit's MSAT team as a Process Development Engineer, offering essential technical and operational support for consumable and cartridge manufacturing. This role bridges new product implementation and process optimization to maintain quality, yield, and robust operations in a dynamic, matrixed, and multinational environment.Key Responsibilities:
Technical Support:
- Troubleshoot and improve manufacturing processes, driving continuous improvement.
- Perform product/process characterization and identify critical parameters; conduct capability studies.
- Develop and maintain production documentation (e.g., Work Instructions), ensuring compliance with quality standards.
- Design and implement In-Process Controls (IPCs) to monitor CTQs.
- Create and manage CTQ-Scorecards for quality tracking.
- Lead/support root cause investigations using structured methodologies (Kepner-Tregoe, 5 Whys, Fishbone Analysis).
- Collaborate across teams for specification development, process characterization, and material qualification.
- Plan/execute Design of Experiments (DOE) and perform statistical analysis (JMP, Minitab).
- Lead initiatives targeting cost reduction, yield improvement, and efficiency.
- Apply Lean Six Sigma methods; maintain process risk documentation (e.g., pFMEA).
- Share and implement best practices across Roche’s global network.
- Ensure adherence to Quality System requirements via effective document and change control.
- Support audits, CAPAs, NCRs, and validation activities.
- Support other duties as assigned.
Education:
- Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical, or related discipline) or equivalent experience.
- 5+ years in medical device, IVD, or regulated manufacturing.
- Experience in GMP or ISO 13485 environment with process validation (IQ/OQ/PQ) and technology transfer.
- Preferred: Microfluidics, surface chemistry, reagent formulation, cartridge production.
- Hands-on with:
- Automated liquid handling, fluidics, and reagent dispensing
- Cleanroom environments
- DOE, SPC, and statistical tools (JMP, Minitab)
- Authoring/maintaining production records in ERP (SAP) Skills & Knowledge:
- Strong communicator and collaborator, with ability to influence at all levels.
- Self-motivated; manages technical tasks/projects independently.
- Proven implementation of in-process controls and CTQ metrics.
- Proficient with structured root cause analysis (Kepner-Tregoe, 5 Whys, Fishbone Analysis).
- Familiar with Lean, Six Sigma (Green Belt preferred), FDA QSR (21 CFR 820), and ISO 13485.
- Lean or Six Sigma (Green Belt preferred or obtainable within 12 months).
- Up to 10% domestic/international, per business requirements.