Penumbra

Quality Engineer II - Catheters

Penumbra • $85K — $114K *
Roseville, CA 95747In-Person
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Associate's or Bachelor's degree in Engineering, Life Science, or related field
  • 2+ years in quality engineering or relevant experience, preferably in medical devices
  • Familiarity with QSR, ISO, and applicable regulations
  • Engineering experience in a manufacturing environment is recommended
  • Excellent communication skills, both verbal and written
  • Proficient in MS Word, Excel, and PowerPoint

Responsibilities

  • Collaborate on the development and qualification of new and existing products
  • Develop testing and inspection methodologies for products
  • Participate in Quality Objective teams to enhance quality standards
  • Design and implement QC process sampling systems and procedures
  • Specify inspection and testing mechanisms and equipment
  • Conduct failure analyses and defect investigations
  • Analyze production limitations and suggest specification revisions
  • Interface with engineers, customers, and suppliers regarding quality issues
  • Assist in developing standard operating procedures
  • Facilitate and conduct internal audits
  • Ensure adherence to the Company’s Quality Management System (QMS) and regulations

Benefits

  • Collaborative work environment in a medical device industry
  • Opportunity to engage with various engineering departments
  • Potential for professional growth and skills development
  • Adherence to national and global quality standards
  • Exposure to innovative quality assurance practices
Full Job Description
General Summary

The Quality Engineer II develops and implements appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. Work with problems of moderate scope where the analysis of situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.

Specific Duties and Responsibilities

  • Collaborate in the development and qualification activities for new and existing products*


  • 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 the regulations, standards, and procedures that are applicable to the Company. *


  • Ensure other members of the department follow the QMS, regulations, standards, and procedures. *


  • Perform other work-related duties as assigned


*Indicates an essential function of the role

Position Qualifications

Minimum education and experience:

  • Associate's or Bachelor's degree in Engineering, a Life Science or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices' environment, or equivalent combination of education and experience.


Additional qualifications:

  • Familiarity with QSR, ISO and other applicable regulations and laws required


  • Engineering experience in a manufacturing environment recommended, medical device industry preferred


  • Excellent verbal, written, and interpersonal communication skills


  • Proficiency with MS Word, Excel, and PowerPoint


Working Conditions

  • Annual Base Salary Range: $85,000 to $114,000


  • Location: Roseville, CA


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 or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.


  • Must be able to read, prepare emails, and produce documents and spreadsheets.


  • Must be able to move within the office and access file cabinets or supplies, as needed.


  • Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.


About Penumbra

Penumbra is a global healthcare company that designs, develops, manufactures, and markets innovative medical devices for the diagnosis and treatment of neurological and vascular diseases. The company's products include clot retrieval devices, neurovascular stents, and more. Penumbra serves a variety of markets including hospitals, clinics, and ambulatory surgery centers. With a commitment to improving patient outcomes, Penumbra is dedicated to advancing the field of interventional medicine through innovation and collaboration.
Learn more about Penumbra
Size
3,800 employees
Market Cap
$8.4 billion
Industry
Healthcare
Net Income
-$15.7 million
Founded
2004
5 Year Trend
+23.2%
Revenue
$560.4 million
NASDAQ
PEN
* Ladders Estimates

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