Senior Process Development Engineer

The Fountain Group; California, Santa Clara (MO, CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Process Development Engineer to enhance manufacturing operations. This role involves providing technical support, driving process improvements, and ensuring compliance with quality standards. The ideal candidate will collaborate with cross-functional teams, lead quality initiatives, and utilize statistical tools for process optimization. If you are passionate about advancing manufacturing technologies and thrive in a dynamic environment, this is an exciting opportunity to make a significant impact.

Qualifications

• 5+ years of experience in medical device or regulated manufacturing roles.
• Proficiency in DOE, SPC, and statistical tools.

Responsibilities

• Provide hands-on support to troubleshoot manufacturing processes.
• Lead strategic improvement initiatives targeting cost reduction.

Skills

Process Improvement

Statistical Analysis

Root Cause Analysis

Lean Six Sigma

Technical Documentation

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

JMP

Minitab

SAP

Job description

As a member of the Roche Sequencing Unit's Manufacturing Sciences and Technology (MSAT) team, the Senior Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. This role bridges new product implementation and process optimization to maintain high product quality, improve yields, and enhance manufacturing robustness. The role operates within a matrix organization, collaborating with cross-functional and multinational teams to ensure compliance, process capability, and product supply integrity.

Responsibilities:
Technical Support:

• Provide hands-on support to troubleshoot manufacturing processes and drive improvement initiatives.
• Conduct product and process characterization, including capability studies and identification of critical parameters.
• Author and maintain Work Instructions and other production-related documentation in compliance with quality standards.
• Design and implement In-Process Controls (IPCs) to monitor CTQs during manufacturing.
• Develop and maintain CTQ-Scorecards to track performance against quality attributes.
• Lead or support root cause investigations using structured methodologies (e.g., Kepner-Tregoe, 5 Whys, Fishbone Analysis).
• Partner with cross-functional teams for specification development, process characterization, and material qualification.
• Plan and execute Design of Experiments (DOE) and perform statistical analysis using tools such as JMP or Minitab.

Continuous and Process Improvement:

• Lead strategic improvement initiatives targeting cost reduction, yield improvement, and process efficiency.
• Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., pFMEA).
• Collaborate across the Roche network to share and implement best practices.

Quality Mindset:

• Ensure compliance with Quality System requirements through document control, change management, and monitoring.
• Participate in and support audits, CAPAs, NCRs, and validation of methods and systems.

Qualifications:

• Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline and minimum 5 years’ experience in medical device, IVD, or regulated manufacturing roles. Equivalent combinations of education and/or experience are acceptable.
• Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production preferred.
• Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).
• Prior experience authoring and managing production documentation in ERP systems (e.g., SAP).
• Demonstrated experience implementing in-process controls and CTQ metrics.
• Familiarity with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis.
• Familiarity with Lean and Six Sigma principles (Green Belt certification preferred).

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