Job Description

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.
• Other duties as assigned by management.

QUALIFICATIONS

Formal Training/Education

Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related

discipline. Equivalent combinations of education and/or experience are acceptable.

Experience

• Minimum 5 years in medical device, IVD, or regulated manufacturing roles.
• 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).

Knowledge, Skills and Abilities

Strong communication, collaboration, and influencing skills across all levels.

Ability to independently manage technical tasks and projects with minimal supervision.

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).

Licenses and Certifications (OPTIONAL)

LEAN/Six Sigma Certification – Green Belt preferred (attainable within 12 months).

Travel Requirements

Estimated Amount: 10%

Brief Description: Domestic and international travel based on business needs.

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