Penumbra

Therapy Development Specialist

Market Access Intern

Sr. Manager, Hospital Engagement

Senior Product Marketing Manager Neurovascular - EMEA

Senior Product Marketing Manager, Neurovascular Germany & Austria

Principal Statistician

In-House Clinical Research Associate II

Clinical Study Manager

Equipment Technician II, Roseville, CA (Day Shift)

Therapy Development Specialist (Houston, TX / San Antonio, TX)

<div class="section page-centered" data-qa="job-description"><div>As a member of the Manufacturing Engineering group at Penumbra, you will be called upon to solve complex problems and implement innovative solutions. You will provide manufacturing technology and robust solutions aimed at continuously improving production processes. Working cross-functionally with engineering groups across the company, as well as with Production, Quality Control and Quality Assurance, you will resolve problems encountered on the production floor and throughout the business, and will apply your engineering knowledge and creativity to implement adaptations and modifications to the production line and to quality systems.&nbsp; &nbsp;&nbsp;</div></div><div class="section page-centered"><div><h3>What You'll Work On</h3><ul class="posting-requirements plain-list"><ul><li>Solve complex problems and implement innovative solutions</li><li>Execute detailed root cause analysis and recommend vetted solutions</li><li>Communicate and explain problems and solutions cross-functionally and inter-departmentally</li><li>Approach problems from a detail-oriented perspective</li><li>Suggest independent recommendations for project approach, scope, and tactics</li><li>Support production needs</li><li>Create and maintain product and process documentation</li><li>Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield</li><li>Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line</li><li>Test processes, equipment, raw materials, and product</li><li>Perform process validations</li><li>Author protocols to execute tests and write reports and make conclusions and/or recommendations based on test results </li><li>Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project</li><li>Develop specifications of a product, process, or piece of equipment</li><li>Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience</li><li>Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans</li><li>Participate in project planning and scheduling</li><li>Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation</li><li>Comply with quality system regulations, standards and procedures</li><li>Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.</li><li>Ensure other members of the department follow the QMS, regulations, standards and procedures.</li><li>Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects.</li></ul></ul></div></div><div class="section page-centered"><div><h3>What You Bring</h3><ul class="posting-requirements plain-list"><ul><li>A passion for tackling and solving technical problems preferred</li><li>The ability to communicate complex issues in a clear, compelling manner, both orally and in writing preferred</li><li>Proven work history of growing within an organization, learning its systems, and showing initiative preferred</li><li>Proven track record of solving problems creatively preferred</li><li>Medical device experience strongly preferred</li><li>Proven knowledge of FDA regulations, lean manufacturing, and/or materials and manufacturing processes preferred</li><li>BS degree in Mechanical, Biomedical, Chemical, or Materials Engineering, or a related discipline required</li><div><br></div></ul></ul></div></div><div class="section page-centered" data-qa="closing-description"><div><b>What We Offer</b></div><div>•A collaborative teamwork environment where learning is constant, and performance is rewarded.</div><div>•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.</div><div>•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&amp;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).</div><div>&nbsp;</div><div>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.</div><div>&nbsp;</div><div><i>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.</i></div><div>&nbsp;</div><div>If you reside in the State of California, please also refer to&nbsp;<a href="https://www.penumbrainc.com/pdf/privacynotice/">Penumbra's Privacy Notice for California Residents.</a></div><div>&nbsp;</div><div>For additional information on Penumbra’s commitment to being an equal opportunity employer, please&nbsp;<a href="https://tinyurl.com/Penumbra-AAP-Policy-Statement">Penumbra's AAP Policy Statement.</a></div></div>

Manufacturing Engineer I