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

bjVSSVNITVVMWVpRZnhPbzhmS1pZWUQxS2c9PQ==
  • 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

Boca Prep International School

Dean of students Job at Boca Prep International School

 ...with families when disciplinary action is required. This is a part-time role and will be combined with other duties e.g. a partial...  ...learning environment Generate infraction notices as needed and immediately contact families to inform them of the issue Oversee... 

Mark One Electric

BIM Designer Job at Mark One Electric

 ...company has evolved and diversified, providing an array of electrical construction services from Design/build and pre-construction to underground, data/comm and specialty systems. Mark One has grown to over 475 employees and is the specialty contractor of choice for Kansas... 

Buckle My Shoe Nursery School

Assistant Preschool Teacher Job at Buckle My Shoe Nursery School

 ...Emilia-inspired infant/toddler program for next year. This is a hands-on, supportive role ideal for someone passionate about early childhood education and eager to grow within a reflective, team-oriented environment. Core Responsibilities: Support Daily Communication... 

Intellectt Inc

Process Design Engineer Job at Intellectt Inc

 ...Role : Design Engineer - Process Location : Clinton, IA (Onsite) Duration : Long-Term Requirements : Education : B.E./B.Tech in Chemical Engineering Experience : 5+ Years of Onsite experience with process and utility diagrams Software Skills... 

Gentle Dental

Dental Assistant Job at Gentle Dental

 ...At Gentle Dental, we value our teammates smile as much as our patients smile. Our vision is to provide exceptional, lifelong, integrated...  ...: $23.00 - $26.00 per hour/DOE Benefits ~ Employee Assistance Program ~ Basic life, AD&D, and long-term disability...