As a Senior Quality Engineer at Penumbra, you will participate in all aspects of process development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identifying problems and determining the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.
What You'll Work On
- Represent Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
- Review and approve engineering change orders on assigned projects and product lines.
- Plan, design, and implement test methods, including test equipment, for inspection of product.
- Evaluate, update, and improve difficult manufacturing processes and engineering systems for assigned product lines.
- Work with suppliers to continually improve technical processes, reliability, and inspections to meet Penumbra's quality standards.
- Take the lead on drafting and implementing risk analysis documentation for new and current products with identified hazards and harms.
- Provide leadership and guidance, in the scope of quality systems, to ensure compliance within designated projects and product lines.
- Lead nonconforming report investigations and recommend appropriate corrective actions.
- Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
- Apply statistical rationale to plan, analyze, and interpret engineering test data collected during new testing.
- Provides leadership and mentoring to more junior staff. May supervise junior engineers.
What You'll Bring
- 4-6 years of experience in biomedical, mechanical, chemical, or materials engineering plus Bachelor's degree in an engineering or scientific field.
- A passion for detailed analysis and problem solving.
- A knack for solving mechanical problems effectively.
- The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.
- The ability to present issues, plans and objectives in a clear, compelling way, both orally and in writing.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
- Solid knowledge of sterilization, biocompatibility, and transportation and shelf life standards
- Working knowledge of data collection, data analysis, and evaluation, and scientific method.
- R&D or new product development experience helpful.·
- ASQ CQE preferred.
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.
- Roseville, CA
-
Starting Base Salary is $107,238/year - $142,564/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.
