Supports development and qualification of medical devices by implementing quality systems, designing testing and inspection methods, applying statistical sampling, performing failure and defect investigations, and analyzing design controls. The role ensures compliance with QMS requirements, QSR, ISO standards, and applicable regulations while collaborating with product development teams, internal departments, customers, and suppliers.
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
Location and Pay
• Alameda, CA
• Annual Base Salary Range: $80,000 to $105,000
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.
What We Offer
• 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.
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.
Penumbra Alameda, California, USA Office
Alameda, CA, United States, 94502
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