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Quality Electrical Engineer II - Medical Device

Quality Electrical Engineer II - Medical Device

PenumbraSanta Rosa, CA, United States
6 hours ago
Job type
  • Full-time
Job description

General Summary

Join our team as a Quality Electrical Engineer II, where you will play a crucial role in developing and implementing quality system elements to ensure our products meet high standards of quality and comply with applicable regulations. This position is ideal for those who enjoy solving problems and making impactful decisions in a dynamic environment.

Specific Duties and Responsibilities

  • Collaborate on the development and qualification activities for new and existing products.
  • Perform PCB function verification to validate critical parameters like power and signal integrity margins against design specifications.
  • Maintain a log of critical hardware PCB issues, document findings, and ensure clear communication with relevant stakeholders.
  • Assist in creating testing and inspection methodologies and documentation for products.
  • Contribute to Quality Objective teams to achieve departmental goals.
  • Design and implement quality control sampling systems, procedures, and statistical techniques.
  • Design or specify inspection and testing mechanisms and equipment.
  • Conduct failure analyses and defect investigations to identify root causes.
  • Analyze production limitations and standards, recommending revisions to specifications as needed.
  • Interface with engineering teams, customers, and suppliers on quality-related issues.
  • Help develop standard operating procedures that align with quality management practices.
  • Facilitate and conduct internal audits to ensure compliance.
  • Adhere to our Quality Management System (QMS) and relevant domestic and global quality regulations.
  • Ensure team compliance with security, privacy, and other regulatory principles.
  • Support and guide other department members in upholding QMS and standards.
  • Perform other work-related duties as assigned.

Location and Salary :

Location : Alameda, CA

Salary : $95,000 to $127,000

Individual compensation will vary based on factors such as performance, skill level, and work location.

Position Qualifications

Minimum education and experience : Associate's or Bachelor’s degree in Engineering, Life Science, or related field with 2+ years in quality engineering or relevant experience, preferably in a medical devices or regulated industry environment.

Additional Qualifications :

  • Familiarity with QSR, ISO, and other applicable regulations is required.
  • Experience in a manufacturing environment, particularly in the medical device industry, is recommended.
  • Proven experience with electronic devices and PCBA.
  • Excellent verbal, written, and interpersonal communication skills are essential.
  • Proficient in MS Word, Excel, and PowerPoint.
  • Working Conditions

  • Work will be conducted in general office, laboratory, and cleanroom environments.
  • Potential exposure to blood-borne pathogens.
  • Must be able to lift and move items weighing up to 25 pounds.
  • Ability to move between buildings and floors is required.
  • Must be able to stay stationary and use a computer or office equipment for extended periods.
  • Must effectively read, write, and communicate with employees at all levels.
  • What We Offer

    Be a part of a collaborative team that values continuous learning and recognizes strong performance. You'll be contributing to innovative therapies that address some of the world’s most challenging diseases.

    We provide a generous benefits package for eligible employees, including medical, dental, and vision insurance, life insurance, short and long-term disability coverage, a 401(k) plan with employer match, an employee stock purchase plan, paid parental leave, eleven company-paid holidays, a minimum of fifteen days of accrued vacation which increases with tenure, and paid sick time.

    Penumbra, Inc. is headquartered in Alameda, California, and is dedicated to developing and marketing innovative therapies for various medical conditions. We proudly serve healthcare providers and sell to hospitals in the U.S., Europe, Canada, Australia, and beyond through distributors.

    We are an equal opportunity employer. All qualified applicants will be considered 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.

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