{"schemaVersion":"jobsearcher.job.v1","id":"ffa67a1ca91726288367da7c","url":"https://jobsearcher.com/jobs/ffa67a1ca91726288367da7c","canonicalUrl":"https://jobsearcher.com/jobs/ffa67a1ca91726288367da7c","title":"Sr. Development Quality Engineer","description":"General Summary\n\nThe Senior Development Quality Engineer leads Quality Engineering responsibilities as part of a product development team to design and qualify new life-saving products. This role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for design, manufacturing, and inspection. Implement design control requirements and provide quality engineering support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.\n\nSpecific Duties and Responsibilities\n\nLead in the development and qualification activities for new and existing products.*\nLead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of engineering work for projects with various scopes. *\nPerform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements. *\nDesign and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment.\nDevelop and validate measurement methods.\nMonitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control requirements per regulatory and industry standards\nSupport developmental projects in the area of quality engineering\nAnalyze reports and recommend corrective and preventive action to adverse results.\nPerform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications.\nSupport activities during FDA inspections and notified body audits. *\nParticipate in the development of standard operating procedures. *\nDevelop and approve documentation for inspection/testing procedures. *\nPerform responsibilities required by the Quality System and other duties as assigned.\nAdhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *\nUnderstand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *\nEnsure other members of the department follow the QMS, regulations, standards, and procedures. *\nPerform other work-related duties as assigned.\n\n*Indicates an essential function of the role\n\nPosition Qualifications\n\nMinimum education and experience:\n\nBachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience\n\nAdditional qualifications:\n\nAdvanced degree preferred\nExperience in auditing, design review, sterilization, project management, and/or product development highly desired\nDemonstrated knowledge of engineering and scientific principles\nHigh proficiency with computers and software applications\nMedical device, pharmaceutical, biotech, and/or other regulated industry experience desired\nStrong oral, written, and interpersonal communication skills\nHigh degree of accuracy and attention to detail\nProficiency with MS Word, Excel, and PowerPoint\nExcellent organizational skills with ability to prioritize assignments while handling various projects simultaneously\n\nLocation and Pay\n\n• Alameda, CA\n• Annual Base Salary Range: $125,000 to $175,000\n\nWe offer a competitive compensation package plus a benefits and equity program, when applicable.\n\nIndividual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.\n\nWorking Conditions\n\nGeneral office, laboratory, and cleanroom environments.\nBusiness travel from 0% - 10%.\nPotential exposure to blood-borne pathogens.\nRequires some lifting and moving of up to 25 pounds.\nMust be able to move between buildings and floors.\nMust be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.\nMust be able to read, prepare emails, and produce documents and spreadsheets.\nMust be able to move within the office and access file cabinets or supplies, as needed.\nMust be able to communicate and exchange accurate information with employees at all levels on a daily basis.\nWhat We Offer\n• A collaborative teamwork environment where learning is constant, and performance is rewarded.\n• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.\n• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).\n\nPenumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.\n\nQualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.\n\nIf you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.\n\nFor additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.","company":"Penumbra","rawCompany":"penumbra","city":"Alameda","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-31T08:46:38.339Z","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":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Development Quality Engineer","description":"General Summary\n\nThe Senior Development Quality Engineer leads Quality Engineering responsibilities as part of a product development team to design and qualify new life-saving products. This role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for design, manufacturing, and inspection. Implement design control requirements and provide quality engineering support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.\n\nSpecific Duties and Responsibilities\n\nLead in the development and qualification activities for new and existing products.*\nLead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of engineering work for projects with various scopes. *\nPerform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements. *\nDesign and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment.\nDevelop and validate measurement methods.\nMonitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control requirements per regulatory and industry standards\nSupport developmental projects in the area of quality engineering\nAnalyze reports and recommend corrective and preventive action to adverse results.\nPerform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications.\nSupport activities during FDA inspections and notified body audits. *\nParticipate in the development of standard operating procedures. *\nDevelop and approve documentation for inspection/testing procedures. *\nPerform responsibilities required by the Quality System and other duties as assigned.\nAdhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *\nUnderstand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *\nEnsure other members of the department follow the QMS, regulations, standards, and procedures. *\nPerform other work-related duties as assigned.\n\n*Indicates an essential function of the role\n\nPosition Qualifications\n\nMinimum education and experience:\n\nBachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience\n\nAdditional qualifications:\n\nAdvanced degree preferred\nExperience in auditing, design review, sterilization, project management, and/or product development highly desired\nDemonstrated knowledge of engineering and scientific principles\nHigh proficiency with computers and software applications\nMedical device, pharmaceutical, biotech, and/or other regulated industry experience desired\nStrong oral, written, and interpersonal communication skills\nHigh degree of accuracy and attention to detail\nProficiency with MS Word, Excel, and PowerPoint\nExcellent organizational skills with ability to prioritize assignments while handling various projects simultaneously\n\nLocation and Pay\n\n• Alameda, CA\n• Annual Base Salary Range: $125,000 to $175,000\n\nWe offer a competitive compensation package plus a benefits and equity program, when applicable.\n\nIndividual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.\n\nWorking Conditions\n\nGeneral office, laboratory, and cleanroom environments.\nBusiness travel from 0% - 10%.\nPotential exposure to blood-borne pathogens.\nRequires some lifting and moving of up to 25 pounds.\nMust be able to move between buildings and floors.\nMust be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.\nMust be able to read, prepare emails, and produce documents and spreadsheets.\nMust be able to move within the office and access file cabinets or supplies, as needed.\nMust be able to communicate and exchange accurate information with employees at all levels on a daily basis.\nWhat We Offer\n• A collaborative teamwork environment where learning is constant, and performance is rewarded.\n• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.\n• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).\n\nPenumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.\n\nQualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.\n\nIf you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.\n\nFor additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.","datePosted":"2026-08-31T08:46:38.339Z","dateModified":"2026-08-31T08:46:38.339Z","hiringOrganization":{"@type":"Organization","name":"Penumbra","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Alameda","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ffa67a1ca91726288367da7c"},"url":"https://jobsearcher.com/jobs/ffa67a1ca91726288367da7c"}}