Process Development Engineer (Life Sciences/Biotechnology/Medical Devices)

Our client, a world leader in diagnostics and life sciences, is looking for a "Process Development Engineer based out of Santa Clara, CA.

Job Duration: Long Term Contract (Possibility Of Further Extension & Conversion)

Pay Rate: $65-$70/hr on W2

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

As a member of the Manufacturing Sciences and Technology (MSAT) team, the Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. He 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:

• Provide hands-on support to troubleshoot manufacturing processes and drive improvement
• 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.
• 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.

Qualification & Skills:

• Bachelor s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Equivalent combinations of education and/or experience are acceptable.
• 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).

If interested, please send us your updated resume at /