{"schemaVersion":"jobsearcher.job.v1","id":"bc26ed09fef511734722e5e0","url":"https://jobsearcher.com/jobs/bc26ed09fef511734722e5e0","canonicalUrl":"https://jobsearcher.com/jobs/bc26ed09fef511734722e5e0","title":"Quality Engineer - Process Development","description":"Design Quality Engineer - Process Development to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space. This individual will drive process validation strategies, lead process risk management (PFMEA), and serve as a critical crossfunctional liaison between internal Supplier Quality, R&D, Contract Manufacturers, and NPI teams. The ideal candidate brings deep expertise in process development, FMEA methodologies, and regulatory compliance -A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential. Process Development & Validation • Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs. • Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up. • Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), nd Cell Operating System (COS). • Drive risk mitigation approaches by integrating qualification parts early in process development phases Process Risk Management & Risk Navigation • Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up. • Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps. • Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk ssessment decisions. • Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition. • Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques Cross-Functional Engagement & Collaboration • Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI program teams • Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation. • Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer • Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness. • Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards. • Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations. • Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections. Production Scale-Up Support & Crisis Management • Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization. • Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA). • Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues. • Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines. Statistical Analysis & Data-Driven Decision Making • Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab. • Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & No. EEO: \"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.\"","company":"Mindlance","rawCompany":"mindlance","city":"Los Angeles","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-07-14T00:36:56.780Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer - Process Development","description":"Design Quality Engineer - Process Development to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space. This individual will drive process validation strategies, lead process risk management (PFMEA), and serve as a critical crossfunctional liaison between internal Supplier Quality, R&D, Contract Manufacturers, and NPI teams. The ideal candidate brings deep expertise in process development, FMEA methodologies, and regulatory compliance -A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential. Process Development & Validation • Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs. • Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up. • Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), nd Cell Operating System (COS). • Drive risk mitigation approaches by integrating qualification parts early in process development phases Process Risk Management & Risk Navigation • Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up. • Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps. • Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk ssessment decisions. • Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition. • Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques Cross-Functional Engagement & Collaboration • Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI program teams • Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation. • Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer • Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness. • Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards. • Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations. • Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections. Production Scale-Up Support & Crisis Management • Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization. • Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA). • Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues. • Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines. Statistical Analysis & Data-Driven Decision Making • Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab. • Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & No. EEO: \"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.\"","datePosted":"2026-07-14T00:36:56.780Z","dateModified":"2026-07-14T00:36:56.780Z","hiringOrganization":{"@type":"Organization","name":"Mindlance","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Los Angeles","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bc26ed09fef511734722e5e0"},"url":"https://jobsearcher.com/jobs/bc26ed09fef511734722e5e0"}}