Product Evaluation Engineer II

Alameda, CA
Quality – Quality Assurance /
External /
On-site
As a Product Evaluation Engineer II, you will play a pivotal role helping Penumbra investigate customer complaints by conducting performance failure evaluations on returned products and determining technical aspects of the failure modes. You will also prepare and provide reports to management on your findings and trends.
 
What You’ll Work On
• Conducts analysis of returned product and investigates complaints that device may not meet specifications
• Performs failure analysis of products, materials, and processes to level necessary to determine root cause and prevent or correct complaints, non-conformances, and product failures
• Works with R&D, and Manufacturing Engineering, and Quality Engineering groups to develop new analytical methods for failure analyses when new products are launched
• Partners with groups including but not limited to Marketing, Sales, Clinical, R&D, and Regulatory to provide quantifiable data in response to the needs of each department
• Documents analysis and investigation findings
• Supports the generation of monthly trending reports and analysis of complaints and investigations
• Assists in determining Failure Mode Effects Analysis (FMEA) rates in support of failure analyses and product risk management
• Conducts data queries and develops reports in association with Health Hazard Evaluation (HHE) activities
• Supports internal and external audit activities as required
• Prepares and facilitates communication with other departments as needed (i.e., RMA, Sales, Supplier Quality, etc.)
• Mentors Product Evaluation Technicians, Engineering Interns and junior staff members on product evaluations and report writing
 
What You Contribute
• A Bachelor’s degree with 2+ years of engineering experience, or equivalent combination of demonstrated education and experience.
• A degree in Engineering or related field is preferred
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired
• Working knowledge of FDA, international medical device regulations and standards, and Good Manufacturing Practices (GMP)
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
 
Working Conditions
General office, production, and cleanroom environments. Willingness and ability to work on site. May have business travel from 0% - 15%. May be required to travel to off-site (hospital) locations in order to perform device analyses at those locations. 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.
 
Annual Base Salary Range:  $75,000 - $105,000 / year
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.  
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, an employee stock purchase plan, 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 Penumbra's AAP Policy Statement.