Quality Engineer II
Job Summary
Job Description
As a Quality Engineer II at Penumbra, you will be responsible for the quality of innovative medical devices used to treat challenging diseases. You will tackle highly technical problems, impacting patient safety globally throughout the product lifecycle, from concept to commercialization and continuous improvement. Key responsibilities include experience on production lines for high-performing catheter products, independently applying the Penumbra Quality Management System to manufacturing, supplier quality, and new product development. You will identify and drive process, yield, and cycle time improvements, determine root causes of quality assurance issues, and ensure adherence to the QMS and relevant regulations for yourself and others.
Must have:
- 2+ years experience in manufacturing/laboratory
- Bachelor's or Master's in engineering/science
- Experience on production lines
Good to have:
- Medical device experience
- Injection molding & tooling development
- Clear written/oral communication
- Passion for impactful products
- Thrive in fast-paced environments
- Collaborative team player
Perks:
- Collaborative teamwork environment
- Rewarding performance
- Revolutionize disease treatment
- Generous benefits package
- Medical, dental, vision insurance
- Life, AD&D, disability insurance
- 401(k) with employer match
- Employee stock purchase plan
- Paid parental leave
- Eleven paid company holidays
- Minimum fifteen days vacation
- Paid sick time
4 skills required
Job Details
As a Quality Engineer, you will be charged with the quality behind Penumbra's game-changing medical devices used to address some of the world's toughest disease states! At Penumbra, we provide our quality engineers with highly technical problems to solve. Your efforts will directly impact the safety of patients around the world who use our products. You will apply your passion for creative problem solving throughout all stages of the process, from concept to commercialization and into continuous improvements.
What You'll Work On
- Experience on production lines manufacturing high performing catheter products
- Independently provide knowledge of Penumbra Quality Management System as it pertains to sustaining manufacturing operations as well as dealing with supplier quality and developing new products
- Identify and drive areas of opportunity for process improvement, yield improvement, and cycle time reduction
- Determine root-cause of in-process quality assurance issues
- Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
- Ensure other members of the department follow the QMS, regulations, standards and procedures.
- Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects.
What You'll Bring
- 2+ years experience in a manufacturing or laboratory environment required; medical device experience preferred; injection molding & tooling development preferred
- A strong drive to work on products that have a meaningful impact on peoples' lives
- Proven ability to thrive in a fast-paced work environment where navigating grey areas is a welcomed challenge
- A Bachelor’s or Master's degree in an engineering or scientific discipline required
- Clear and concise written and oral communication skills preferred
- A passion for working in collaborative and dynamic teams with a feedback-rich culture
Working Conditions
- General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
- Alameda, CA
- Starting Base Salary is $95,000/year - $127,000/year.
- Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.
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 see Penumbra's AAP Policy Statement.
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