R&D Partners
Overview
This range is provided by R&D Partners. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$84,115.00/yr - $137,072.00/yr This is a 12-month contract based in Santa Clara, California. 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 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
Bachelors 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. 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. Working in a cleanroom environment. Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab). Prior experience authoring and managing production documentation in ERP systems (e.g., SAP). 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. Licenses and Certifications optional. Travel Requirements: Domestic and International Travel estimated amount 10%. Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including: Medical insurance PPO, HMO & HSA 401k plan Employee Assistance Program Long-term disability Weekly payroll Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Seniority level
Associate Employment type
Contract Job function
Manufacturing Industries
Staffing and Recruiting Biotechnology Research R&D Partners is an equal-opportunity employer. #J-18808-Ljbffr
This range is provided by R&D Partners. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$84,115.00/yr - $137,072.00/yr This is a 12-month contract based in Santa Clara, California. 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 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
Bachelors 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. 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. Working in a cleanroom environment. Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab). Prior experience authoring and managing production documentation in ERP systems (e.g., SAP). 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. Licenses and Certifications optional. Travel Requirements: Domestic and International Travel estimated amount 10%. Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including: Medical insurance PPO, HMO & HSA 401k plan Employee Assistance Program Long-term disability Weekly payroll Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Seniority level
Associate Employment type
Contract Job function
Manufacturing Industries
Staffing and Recruiting Biotechnology Research R&D Partners is an equal-opportunity employer. #J-18808-Ljbffr