Our goal is to redefine IT staffing by embracing diversity and inclusion, connecting clients with exceptional and skilled professionals who bring innovative solutions while fostering an environment where every individual feels valued and empowered to thrive.
Process Development Engineer II
Type: Contract, W2 only
Duration: 12+ months
Location: onsite in Santa Clara, CA
Pay: $56/hr-$83/hr, DOE
Travel: 10%
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
A global biotechnology leader is seeking a Process Development Engineer to provide 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 company's 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.
- Other duties as assigned by management.
Qualifications:
- 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 working in a GMP or ISO 13485 compliant manufacturing environment, with direct involvement in process validation (IQ/OQ/PQ) and technology transfer from R&D to Operations.
- Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production preferred.
- Demonstrated experience implementing in-process controls and CTQ metrics.
- Demonstrated ability with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis.
- Familiarity with Lean and Six Sigma principles (Green Belt certification preferred).
- Working knowledge of FDA Quality System Regulation (QSR) 21 CFR 820 and ISO 13485 standards.
Hands-on experience in several of the following areas is highly desirable:
- Biosensor or semiconductor manufacturing, especially processes involving functionalized surfaces.
- Automated liquid handling, reagent dispensing, and precision fluidics.
- Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).
- Prior experience authoring and managing production documentation in ERP systems (e.g., SAP).
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.