Process Development Engineer Job at BEPC Inc. - Business Excellence Professional Consulting, Santa Clara, CA

ZGxLTnZZanY0Nzl0NThiSm9EcUUxbVZpc2c9PQ==
  • BEPC Inc. - Business Excellence Professional Consulting
  • Santa Clara, CA

Job Description

Bepc, Inc has an open position for a Process Development Engineer in Santa Clara, CA!!

W2 Contract 12 months with the possibility of extensions

Pay and Benefits-$65-$70 an hour -Medical, Dental, Vision, Paid Life Insurance

Process Development Engineer Onsite Position -

This contractor 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. 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.

Job Tags

Contract work, For contractors,

Similar Jobs

Max Mara Fashion Group

Tailor/Seamstress, MaxMara Beverly Hills Flagship (TEMP) Job at Max Mara Fashion Group

 ...distance, as well as use peripheral vision and depth perception, and be able to look at, read, and use a computer, electronic devices and phones for long periods of time. Requirements ~ High school diploma or equivalent degree ~3-4 years prior retail experience in... 

CBSLLC

AWS Data Engineer (No C2C) Job at CBSLLC

 ...Key Responsibilities: Design and build scalable and reliable data pipelines using AWS services such as Glue, Lambda, S3, Redshift, and EMR. Develop ETL/ELT processes to transform and load structured and unstructured data from various sources. Optimize performance... 

NTD

Video Photojournalist Job at NTD

 ...video footage of events, interviews, and press conferences in Washington DC based on the needs and requirements of the newsroom. Operate camera equipment to achieve optimal image and sound quality, and adjust equipment, lighting, and sound as needed. Work... 

Chamblee Ryan, P.C.

Litigation Paralegal Job at Chamblee Ryan, P.C.

 ...Chamblee Ryan, PC is looking for a litigation paralegal to add to the team. The ideal candidate will have at least 4+ years of defense litigation experience. Primary Duties & Responsibilities: Manage high volume of files from inception to trial. Draft and analyze... 

Biz2Credit

Senior Product Manager Job at Biz2Credit

About US At Biz2Credit, we look for individuals who are ready to join a dynamic and innovative fintech company on a mission to change the lending landscape for small businesses. Our values of Collaboration, Responsibility, Empowerment, Disruption, Innovation, and Trust...