General Summary
The Development Quality Engineer I works with product development teams to design and qualify new life-saving products. You will help develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products and to ensure their compliance to all applicable regulations and standards. Help products safely and efficiently get to market by following standards and procedures to analyze situations and data from which conclusions can be readily obtained.
Specific Duties and Responsibilities
- Participate in the product development and qualification activities for new and existing products*
- Participate in Product Development teams*
- Develop testing, inspection methodology, and documentation for new and existing products*
- Design and install quality sampling systems and procedures utilizing statistical analysis*
- Design or specify inspection and testing equipment to meet product requirements*
- Perform failure analyses and defect investigations*
- Analyze and apply design control standards*
- Recommend revision of specifications, procedures, and work instructions for device design and process improvement*
- Interface with other internal departments, customers, and suppliers on product and quality-related issues*
- 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, plus quality engineering or relevant experience, preferably in a medical device environment, or equivalent combination of education and experience
Additional qualifications:
- Familiarity with QSR, ISO and other applicable regulations and laws required
- Excellent verbal, written, and interpersonal communication skills
- Proficiency with MS Word, Excel, and PowerPoint
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.
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.
Skills Required
- Associate's or Bachelor's degree in Engineering, Life Science, or a related field, or equivalent combination of education and experience
- Quality engineering or relevant experience
- Familiarity with QSR, ISO, and other applicable regulations and laws
- Excellent verbal, written, and interpersonal communication skills
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Experience in a medical device environment
Penumbra Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Penumbra and has not been reviewed or approved by Penumbra.
-
Healthcare Strength — Company materials describe comprehensive medical, dental, and vision coverage with immediate eligibility, alongside life and disability insurance. Feedback suggests health coverage quality is a standout element of the package.
-
Parental & Family Support — Company sources indicate fully paid parental leave and on-site support for nursing parents in key locations. Feedback suggests family support policies compare favorably within med‑tech employers.
-
Leave & Time Off Breadth — Company postings outline paid holidays, sick leave, and vacation that increases with tenure. Feedback suggests time‑off provisions are broadly competitive when weighing total package value.
Penumbra Insights
What We Do
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. Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant.
