{"schemaVersion":"jobsearcher.job.v1","id":"3c8fc5b05d3658280fc56b03","url":"https://jobsearcher.com/jobs/3c8fc5b05d3658280fc56b03","canonicalUrl":"https://jobsearcher.com/jobs/3c8fc5b05d3658280fc56b03","title":"Sr Engineer II, Process","description":"Job Summary\r\nThe Sr. Engineer II, Process is responsible for developing, improving, and validating new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports new process development (NPI) and product transfers to worldwide manufacturing facilities, implements and supports/utilizes effective manufacturing methodologies, such as Lean manufacturing, DFM, visual Workshop, SPC, etc., always following local and international regulatory standards (e.g. 21 CFR, Part 820 and ISO 13485:2003).\r\nDuties & Responsibilities:\r\n\r\nAssist in setting up World Class Manufacturing capability for the Company's products.\r\nResponsible for the design/specification/purchase/installation/qualification of the Company's manual/ automated assembly equipment and tooling.\r\nWork closely with design engineering to proactively influence designs for better manufacturability.\r\nDevelop manufacturing plans, project timelines, requirements, specifications, and process flow.\r\nGenerate Manufacturing Assembly and In-Process Acceptance Procedures and train production personnel.\r\nDevelop the Validation Master Plans and perform process validations (IQ, OQ, PQ), including generating protocols and reports.\r\nPerform line setup, line balancing, and build time studies.\r\nLead initial product builds (engineering units, pilot units, process validation units) and coordinate a smooth transfer of new products into production.\r\nDevelop Process Failure Mode and Effects Analyses (PFMEAs).\r\nConduct Design Reviews and prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.\r\nEstablish Statistical Process Controls for Manufacturing Operations.\r\nTechnically support satellite manufacturing plants through effective communication.\r\nDrive continuous improvement of engineering technical capabilities.\r\nContinuously research, learn, and recommend best practices for world-class manufacturing.\r\nMust be able to travel domestically and internationally.\r\nPerform special projects as requested.\r\n\r\nMinimum Qualifications\r\n\r\nAt least seven (7) years of experience in engineering: process, manufacturing, or mechanical.\r\nExperience with optical/ electro-mechanical assembly and testing.\r\nExperience in modern manufacturing principles and techniques.\r\nWorking knowledge of statistical techniques (e.g., DOE, SPC).\r\nExperience in process automation, verification, and validation.\r\nExcellent communication skills and technical writing abilities.\r\nExcellent conceptual, analytical, and problem-solving abilities.\r\nExcellent computer skills - SolidWorks (CSWA), word processing, and spreadsheets.\r\nAbility to work effectively in cross-functional teams.\r\nAbility to work onsite Monday - Friday in Irvine, CA.\r\n\r\nPreferred Qualifications\r\n\r\nProven experience in taking a major device from inception to customer shipment.\r\nProven work experience in process engineering.\r\nWorking Knowledge of 21 CFR, Part 820, and ISO 13485:2003 requirements.\r\nMust be comfortable with integrating new technology into an existing business environment.\r\nExperience with design, development, and validating manufacturing processes for an optical/ electro-mechanical device containing software.\r\nExperience with cable assembly processes including cable preparation, hand soldering, crimping etc.\r\nExperience with plastic injection molding.\r\nExcellent CAD (SolidWorks) skills, CSWP.\r\nWorking knowledge of Geometric Dimensioning and Tolerancing (GD&T).\r\nDemonstrated ability to manage large-scale projects and deliver results on time and within budget.\r\nDesign experience (the ability to design for manufacturability).\r\nBasic device software knowledge.\r\n\r\nEducation: Bachelor's degree in engineering: Mechanical, Electrical, Manufacturing or Industrial Engineering or related field is required.\r\nCompensation\r\nThe anticipated salary range for this position is $120,000 - $155,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.","company":"Masimo","rawCompany":"masimo","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-05-02T19:34:34.665Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334419","title":"Other Electronic Component Manufacturing","slug":"other-electronic-component-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr Engineer II, Process","description":"Job Summary\r\nThe Sr. Engineer II, Process is responsible for developing, improving, and validating new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports new process development (NPI) and product transfers to worldwide manufacturing facilities, implements and supports/utilizes effective manufacturing methodologies, such as Lean manufacturing, DFM, visual Workshop, SPC, etc., always following local and international regulatory standards (e.g. 21 CFR, Part 820 and ISO 13485:2003).\r\nDuties & Responsibilities:\r\n\r\nAssist in setting up World Class Manufacturing capability for the Company's products.\r\nResponsible for the design/specification/purchase/installation/qualification of the Company's manual/ automated assembly equipment and tooling.\r\nWork closely with design engineering to proactively influence designs for better manufacturability.\r\nDevelop manufacturing plans, project timelines, requirements, specifications, and process flow.\r\nGenerate Manufacturing Assembly and In-Process Acceptance Procedures and train production personnel.\r\nDevelop the Validation Master Plans and perform process validations (IQ, OQ, PQ), including generating protocols and reports.\r\nPerform line setup, line balancing, and build time studies.\r\nLead initial product builds (engineering units, pilot units, process validation units) and coordinate a smooth transfer of new products into production.\r\nDevelop Process Failure Mode and Effects Analyses (PFMEAs).\r\nConduct Design Reviews and prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.\r\nEstablish Statistical Process Controls for Manufacturing Operations.\r\nTechnically support satellite manufacturing plants through effective communication.\r\nDrive continuous improvement of engineering technical capabilities.\r\nContinuously research, learn, and recommend best practices for world-class manufacturing.\r\nMust be able to travel domestically and internationally.\r\nPerform special projects as requested.\r\n\r\nMinimum Qualifications\r\n\r\nAt least seven (7) years of experience in engineering: process, manufacturing, or mechanical.\r\nExperience with optical/ electro-mechanical assembly and testing.\r\nExperience in modern manufacturing principles and techniques.\r\nWorking knowledge of statistical techniques (e.g., DOE, SPC).\r\nExperience in process automation, verification, and validation.\r\nExcellent communication skills and technical writing abilities.\r\nExcellent conceptual, analytical, and problem-solving abilities.\r\nExcellent computer skills - SolidWorks (CSWA), word processing, and spreadsheets.\r\nAbility to work effectively in cross-functional teams.\r\nAbility to work onsite Monday - Friday in Irvine, CA.\r\n\r\nPreferred Qualifications\r\n\r\nProven experience in taking a major device from inception to customer shipment.\r\nProven work experience in process engineering.\r\nWorking Knowledge of 21 CFR, Part 820, and ISO 13485:2003 requirements.\r\nMust be comfortable with integrating new technology into an existing business environment.\r\nExperience with design, development, and validating manufacturing processes for an optical/ electro-mechanical device containing software.\r\nExperience with cable assembly processes including cable preparation, hand soldering, crimping etc.\r\nExperience with plastic injection molding.\r\nExcellent CAD (SolidWorks) skills, CSWP.\r\nWorking knowledge of Geometric Dimensioning and Tolerancing (GD&T).\r\nDemonstrated ability to manage large-scale projects and deliver results on time and within budget.\r\nDesign experience (the ability to design for manufacturability).\r\nBasic device software knowledge.\r\n\r\nEducation: Bachelor's degree in engineering: Mechanical, Electrical, Manufacturing or Industrial Engineering or related field is required.\r\nCompensation\r\nThe anticipated salary range for this position is $120,000 - $155,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.","datePosted":"2026-05-02T19:34:34.665Z","dateModified":"2026-05-02T19:34:34.665Z","hiringOrganization":{"@type":"Organization","name":"Masimo","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3c8fc5b05d3658280fc56b03"},"url":"https://jobsearcher.com/jobs/3c8fc5b05d3658280fc56b03"}}