Senior Quality Engineer

General OverviewAs a Senior Quality Engineer with Penumbra Inc, you will play a pivotal role in enhancing our manufacturing operations and production lines for a diverse array of medical devices. Leveraging your strong analytical and problem-solving capabilities, you will maintain process control, bolster inspection and monitoring frameworks, and drive yield…

General SummaryThe Quality Engineer II plays a crucial role in developing and executing robust quality system elements to uphold the excellence of both new and existing product lines. This position ensures compliance with pertinent regulations and standards while addressing moderate-scope problems that require in-depth analysis of identifiable factors. The engineer will exercise sound judgment to determine optimal actions and effectively communicate and implement quality objectives across the organization.Specific Duties and Responsibilities• Collaborate in the development and qualification processes for both new and existing products.• Develop comprehensive testing and inspection methodologies along with associated documentation.• Engage actively with Quality Objective teams.• Design and implement Quality Control (QC) process sampling systems, procedures, and statistical techniques.• Specify or design inspection and testing mechanisms and equipment tailored for product requirements.• Conduct failure analyses and defect investigations to enhance product quality.• Analyze production limitations and standards to recommend improvements.• Suggest revisions to specifications to align with quality standards.• Interface effectively with engineering departments, customers, and suppliers on quality-related issues.• Assist in the creation of standard operating procedures (SOPs).• Facilitate and conduct internal audits to ensure compliance.• Adhere to the Company's Quality Management System (QMS) and global quality regulations and standards.• Understand and comply with relevant security, privacy, and compliance principles.• Ensure adherence to QMS, regulations, standards, and procedures within the department.• Undertake additional work-related duties as assigned.*Indicates essential functions of the role.Location and Salary:• Location: Alameda, CA• Salary: $95,000 to $127,000• Compensation is subject to variation based on performance, skill level, competencies, work location, and shift.Position QualificationsMinimum education and experience: • Associate’s or Bachelor's degree in Engineering, Life Sciences, or a related field, with a minimum of 2 years of relevant experience in quality engineering, preferably within the medical devices or regulated industry, or an equivalent combination of education and experience.Additional Qualifications:• Strong familiarity with Quality System Regulations (QSR), ISO standards, and other applicable regulations and laws related to quality engineering.

OverviewWe are seeking a skilled and experienced Senior Quality Engineer to join our dynamic team at Penumbra Inc. in Alameda, CA. In this pivotal role, you will leverage your engineering expertise to drive quality assurance processes and enhance product reliability. You will be responsible for planning and executing quality initiatives, utilizing your judgment and independent evaluation skills to adapt and refine standard techniques. This position requires innovative problem-solving to overcome engineering challenges and uphold our high-quality standards in manufacturing and design control.Key Responsibilities• Engage in the development and qualification of both new and existing products, ensuring they meet rigorous quality standards.*• Lead project teams to synchronize quality efforts in designing, developing, and continuously enhancing products. This includes planning, scheduling, and coordinating detailed engineering phases for diverse projects.*• Conduct engineering tasks that involve conventional practices while addressing complex features such as conflicting design requirements and material unsuitability.*• Design and implement inspection, testing, and evaluation methods for precision and accuracy of equipment.• Develop and validate measurement methodologies to ensure product compliance.• Oversee design control processes to guarantee new products adhere to guidelines and maintain success metrics in alignment with regulatory standards.• Analyze product reports and returns, recommending corrective and preventive actions to enhance quality.*• Perform statistical analyses to identify accountability for products and materials failing to meet standards.*• Participate in Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) boards as required.*• Conduct Quality System Regulation (QSR) training sessions.*• Assist during FDA inspections, FDB inspections, and notified body audits.*• Collaborate in formulating standard operating procedures.*• Prepare documentation for inspection and testing methods.*• Fulfill responsibilities associated with the Quality System and undertake additional duties as assigned.• Mentor and develop team members, setting objectives and providing ongoing feedback through performance reviews.*• Comply with the Company’s Quality Management System (QMS) and relevant domestic and international regulations.*

At Anthro Energy, we are pioneering the development of cutting-edge electrolytes that will revolutionize lithium-ion battery performance, enhancing safety and efficiency. We are currently on the lookout for a highly skilled and motivated Lead Staff Electrolyte Scientist to spearhead innovative electrolyte solutions, focusing on advanced cell chemistries such as high-Ni, high-voltage NCM, and silicon-dominant anodes.This is a pivotal position for a technical leader who will define and implement electrolyte strategies, tackle critical interfacial challenges, and transform innovative formulations into commercially viable battery systems. You will work at the forefront of electrolyte science, managing projects from foundational design through thorough validation in full cells and commercial integration.Key Responsibilities:Develop and refine the electrolyte formulation strategy for cutting-edge lithium-ion systems, emphasizing high-energy-density and high-voltage chemistries.Design and innovate advanced electrolyte systems, incorporating state-of-the-art additive packages and next-gen formulations optimized for Si-rich anodes and high-Ni cathodes.Address complex interfacial challenges (including SEI/CEI stability, gas evolution, impedance growth, and transition metal dissolution) under demanding operating conditions to ensure long cycle life, rapid charging capabilities, and enhanced safety performance.Drive in-depth mechanistic understanding through a combination of electrochemical techniques and advanced analytical methods, linking molecular design to cell-level behavior.Collaborate closely with cell engineering and materials teams to achieve optimal electrolyte, electrode, and cell design.Lead electrolyte initiatives within commercial programs, ensuring alignment with client needs and manufacturability considerations.Establish technical direction, create experimental frameworks, and enhance data quality and rigor across electrolyte development efforts.Contribute to intellectual property generation and technical differentiation, shaping Anthro’s long-term technology roadmap.