Penumbra, Inc.
Medical Device Quality Electrical Engineer II
Penumbra, Inc., Alameda, California, United States, 94501
Medical Device Quality Electrical Engineer II
Penumbra, Inc. is seeking a Quality Electrical Engineer II to develop and implement quality system elements to ensure high-quality products and regulatory compliance. The role involves problem solving of moderate scope, exercising judgement, and communicating quality objectives across teams. Overview
Location: San Leandro, CA. Salary: $95,000 to $127,000 per year. Individual compensation varies based on performance, skill level, competencies, work location and shift. The candidate should have an engineering or related degree and experience in quality engineering within a regulated environment, preferably medical devices. Responsibilities Collaborate in the development and qualification activities for new and existing products
Perform PCB function verification to ensure all functions meet design specifications, validating critical parameters such as power and signal integrity margins
Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant stakeholders
Collaborate in the development of testing and inspection methodology and documentation for new and existing products
Collaborate on Quality Objective teams
Design and install QC process sampling systems, procedures, and statistical techniques
Design or specify inspection and testing mechanisms and equipment
Perform failure analyses and defect investigations
Analyze production limitations and standards
Recommend revision of specifications
Interface with other engineering departments within the company, customers, and suppliers on quality related issues
Collaborate in the development of standard operating procedures
Facilitate and perform internal audits
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Understand relevant security, privacy and compliance principles and adhere to applicable regulations, standards, and procedures
Ensure other members of the department follow the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned
Qualifications Associate’s or Bachelor’s degree in Engineering, Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry
Familiarity with QSR, ISO and other applicable regulations and laws
Engineering experience in a manufacturing environment; medical device industry preferred
Experience with electronic devices and/or PCBAs
Excellent verbal, written, and interpersonal communication skills
Proficiency with MS Word, Excel, and PowerPoint
Working Conditions General office, laboratory, and cleanroom environments
Potential exposure to blood-borne pathogens
Requires some lifting and moving of up to 25 pounds
Must be able to move between buildings and floors
Must be able to remain stationary and use a computer for extended periods
Must be able to read, compose emails, and produce documents and spreadsheets
Must be able to move within the office to access supplies
Must be able to communicate and exchange accurate information with employees at all levels
What We Offer A collaborative teamwork environment with opportunities for learning and performance-based rewards
Be part of a team addressing challenging medical conditions
Comprehensive benefits for eligible employees including medical, dental, vision, life, AD&D, disability insurance, 401(k) with employer match, employee stock purchase plan, paid parental leave, holidays, vacation, and sick time
Penumbra, Inc. is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products with a broad portfolio. The company operates globally and sells to hospitals and healthcare providers primarily in the United States and other major regions. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified 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.
If you reside in California, please refer to Penumbra’s Privacy Notice for California Residents and Penumbra’s AAP Policy Statement for equal opportunity.
Seniority level
Associate Employment type
Full-time Job function
Medical Equipment Manufacturing
Note: This description preserves the essential responsibilities and qualifications of the role, removes extraneous boilerplate, and uses proper HTML structure with allowed tags only.
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Penumbra, Inc. is seeking a Quality Electrical Engineer II to develop and implement quality system elements to ensure high-quality products and regulatory compliance. The role involves problem solving of moderate scope, exercising judgement, and communicating quality objectives across teams. Overview
Location: San Leandro, CA. Salary: $95,000 to $127,000 per year. Individual compensation varies based on performance, skill level, competencies, work location and shift. The candidate should have an engineering or related degree and experience in quality engineering within a regulated environment, preferably medical devices. Responsibilities Collaborate in the development and qualification activities for new and existing products
Perform PCB function verification to ensure all functions meet design specifications, validating critical parameters such as power and signal integrity margins
Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant stakeholders
Collaborate in the development of testing and inspection methodology and documentation for new and existing products
Collaborate on Quality Objective teams
Design and install QC process sampling systems, procedures, and statistical techniques
Design or specify inspection and testing mechanisms and equipment
Perform failure analyses and defect investigations
Analyze production limitations and standards
Recommend revision of specifications
Interface with other engineering departments within the company, customers, and suppliers on quality related issues
Collaborate in the development of standard operating procedures
Facilitate and perform internal audits
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Understand relevant security, privacy and compliance principles and adhere to applicable regulations, standards, and procedures
Ensure other members of the department follow the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned
Qualifications Associate’s or Bachelor’s degree in Engineering, Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry
Familiarity with QSR, ISO and other applicable regulations and laws
Engineering experience in a manufacturing environment; medical device industry preferred
Experience with electronic devices and/or PCBAs
Excellent verbal, written, and interpersonal communication skills
Proficiency with MS Word, Excel, and PowerPoint
Working Conditions General office, laboratory, and cleanroom environments
Potential exposure to blood-borne pathogens
Requires some lifting and moving of up to 25 pounds
Must be able to move between buildings and floors
Must be able to remain stationary and use a computer for extended periods
Must be able to read, compose emails, and produce documents and spreadsheets
Must be able to move within the office to access supplies
Must be able to communicate and exchange accurate information with employees at all levels
What We Offer A collaborative teamwork environment with opportunities for learning and performance-based rewards
Be part of a team addressing challenging medical conditions
Comprehensive benefits for eligible employees including medical, dental, vision, life, AD&D, disability insurance, 401(k) with employer match, employee stock purchase plan, paid parental leave, holidays, vacation, and sick time
Penumbra, Inc. is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products with a broad portfolio. The company operates globally and sells to hospitals and healthcare providers primarily in the United States and other major regions. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified 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.
If you reside in California, please refer to Penumbra’s Privacy Notice for California Residents and Penumbra’s AAP Policy Statement for equal opportunity.
Seniority level
Associate Employment type
Full-time Job function
Medical Equipment Manufacturing
Note: This description preserves the essential responsibilities and qualifications of the role, removes extraneous boilerplate, and uses proper HTML structure with allowed tags only.
#J-18808-Ljbffr