General Summary
You will have an opportunity to identify and own high impact projects to life saving medical devices. In this opportunity, you will independently support Commercial Operations to ensure the high-quality manufacturing of Class II/III interventional medical devices. This position will provide work with problems of advanced scope where the analysis of situation or data requires a review of identifiable factors. Work with collaborative teams to exercise good judgment to determine appropriate quality actions, and communicate and implement quality objectives.
Specific Duties and Responsibilities
•Support Commercial Operations and Manufacturing activities such as Incoming/In-process/Final Inspections, NCRs, CAPAs, Engineering Change Orders, Control Chart Investigations, Deviation Authorizations, and Equipment sustaining activities.
•Support assigned manufacturing product lines and perform failure analyses and defect investigations as appropriate.
•Execute and collaborate on Continuous Improvement efforts.
•Execute and support supplier activities such as Second Source Qualifications, Supplier Changes, and SCARs.
• Interface with other engineering departments within the company, and suppliers on quality related issues.
• Collaborate and/or help lead in the development of manufacturing documentation.
• Design, improve and support Test Methods, Testing Equipment and TMVs.
• Recommend revisions to specifications, acceptance criteria, and manufacturing documentation to improve quality of product and/or Manufacturing Operations.
• Provide guidance to junior Quality Engineers in support of departmental functions.
• Perform responsibilities required by the Quality System and other duties as assigned or requested.
•Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.
Position Qualifications
Minimum education and experience:
• Associate’s or Bachelor's degree in Engineering, a Life Science or a related field with 3+
years of quality engineering or relevant experience, preferably in a medical devices
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 required
• Leadership skills desired
• Proficiency with MS Word, Excel, and PowerPoint required
Working Conditions
• General office, laboratory, and cleanroom environments
• 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 includes the ability to read, close vision, distance vision, color vision, peripheral
vision, and depth perception.
• Alameda, CA
• Starting Base Salary is $109,760 to $145,920
The above statements are intended to describe the general nature and level of work being
performed by people assigned to this classification. They are not intended to be construed as an
exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
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.
