Process Development Engineer II

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Communication Specialist | Account Manager | Recruiting | Growing in Digital Business Management |

BEPC is actively looking for a Process Development Engineer II in Santa Clara, CA area!

W2 Contract – 1 year with possible extensions!

Benefits include medical, dental, vision, and life insurance

Pay Rate: $61.00 - $71.00/hour - Determined based on experience

Work Setup: Onsite position

Travel: Approximately 10% (domestic and international, based on business needs)

Note : This is a W2 only role — C2C, C2H will not be considered

BEPC is seeking a highly motivated Process Development Engineer to support manufacturing operations for consumables and cartridges. This role will be responsible for providing technical and operational support, implementing process improvements, and ensuring high-quality, robust production outcomes. The engineer will plan and execute process characterization and validation studies, apply advanced engineering principles, and utilize statistical tools to drive optimization. Maintaining accurate documentation and ensuring compliance with quality standards, this position will also lead or support root cause investigations and contribute to continuous improvement initiatives. Partnering with management and cross-functional teams, the Process Development Engineer will play a key role in problem-solving, innovation, and ensuring that manufacturing processes align with project goals and regulatory requirements.

Summary of Duties and 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 (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 (pFMEA).
• Collaborate across the 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:

• 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 in a GMP or ISO 13485 compliant manufacturing environment.
• Direct involvement in process validation (IQ/OQ/PQ) and technology transfer from R&D to Operations.
• Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).
• Prior experience authoring and managing production documentation in ERP systems (e.g., SAP)
• Strong communication, collaboration, and influencing skills across all levels.
• Ability to independently manage technical tasks and projects with minimal supervision.
• Experience implementing in-process controls and CTQ metrics.
• Experience with structured root cause analysis tools (Kepner-Tregoe, 5 Whys, Fishbone Analysis).
• Familiarity with Lean and Six Sigma principles.
• Working knowledge of FDA QSR (21 CFR 820) and ISO 13485 standards.

Preferred Qualifications:

• Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production.
• Hands-on experience in:
• Biosensor or semiconductor manufacturing (especially processes involving functionalized surfaces).
• Automated liquid handling, reagent dispensing, and precision fluidics.
• Working in a cleanroom environment.
• Lean Six Sigma Green Belt certification (preferred, attainable within 12 months)..

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Apply Now!

Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Science and Engineering

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing

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