New · posted Nov 7
Penumbra · Medical Devices
Quality Engineer II - Catheters
- Roseville, CA
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
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.
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
What you'll do
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
Pay
$85,000 – $114,000 a year
Employer provided• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• 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).
Penumbra, 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.
Where you'll work
Roseville, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Roseville, CAWorking conditions
Annual Base Salary Range: $85,000 to $114,000
Location: Roseville, CA
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
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.
Equal opportunity, accessibility and legal noticesPenumbra's statements, word for word
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 the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Job intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Quality Engineering roles at this level.
This roleEmployer provided
Associate & Specialist roles in California7 roles publishing pay
Associate & Specialist roles in the US48 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $85,000 | — | $114,000 |
| California (middle half) | $74,500 | $78,500 | $95,500 |
| All US (middle half) | $73,000 | $84,000 | $99,000 |
This role: Penumbra's own published range. Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 214 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not Penumbra's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Documentation and SOPs6
- Collaboration and leadership6
- Quality systems and risk4
- Lab testing and methods2
- Data and digital systems2
- Investigations and CAPA1
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
Company hiring pulse
Penumbra on Regulatory Jobs
- 16
- Open roles
- 16
- Distinct roles
- 3
- Locations
By discipline
- Quality12 75%
- Regulatory2 13%
- Clinical2 13%
By level
- Senior & Principal8 50%
- Associate & Specialist5 31%
- Manager3 19%
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Quality Engineer II - Catheters at Penumbra
Open until filled. $85K–$114K a year, employer provided.