Sr Quality Engineer - Electronics job opportunity at Penumbra, Inc..

Home Jobs In United States Of America Tag: Engineering – Quality Engineers Sr Quality Engineer - Electronics position at Penumbra, Inc.


bot
Penumbra, Inc. Sr Quality Engineer - Electronics
Experience: 5 Years
Pattern: On-site
Country:
apply Apply Now
Salary:
Status:

Engineering,Quality Engineers

Copy Link Report
degreeBachelor's (B.Sc.)
loacation Alameda, CA, United States Of America
loacation Alameda, CA....United States Of America

General SummaryThe Senior Quality Engineer role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for manufacturing. Monitor design control and provide quality assurance support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.Specific Duties and Responsibilities•Participate in the development and qualification activities for new and existing products.*•Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products.  Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes. *•Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements. *•Perform engineering work including one or more of the following:•Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment•Develop and validate measurement methods•Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards•Support developmental projects in the area of quality assurance•Analyze reports and returned products and recommend corrective and preventive action•Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications•Participate in NCR or CAPA board as necessary•Assist in and perform QSR training. *•Support activities during FDA inspections, FDB inspections, and notified body audits. *•Participate in the development of standard operating procedures. *•Prepare documentation for inspection/testing procedures. *•Perform responsibilities required by the Quality System and other duties as assigned.•Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * •Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * •Ensure other members of the department follow the QMS, regulations, standards, and procedures. * •Perform other work-related duties as assigned.*Indicates an essential function of the rolePosition QualificationsMinimum education and experience:•Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience, preferably in a medical device or regulated industry environmentAdditional qualifications:     •Advanced degree preferred•Experience applying IEC 60601 standards in a medical device environment preferred•Experience with Process Failure Mode and Effects Analysis (PFMEA), sustaining projects, commercial medical device manufacturing, Non-Conformance Reports (NCRs), Failure Investigations, and Change Control•Experience in auditing, design review, sterilization, project management, and/or product development highly desired  •Experience with Electronic devices and or PCBAs•Experience with Contract Manufactured Electromechanical Medical device productsWorking Conditions•General office, laboratory, and cleanroom environments.•Business travel from 0% - 10%. •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.  Location and Pay•Alameda, CA•$125,000 to $175,000\n\nWhat 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, 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.

Other Ai Matches

Legal Compliance Analyst Applicants are expected to have a solid experience in handling General Administration – Legal related tasks
remote-jobserver Remote
Product Marketing Manager Neurovascular Italy & Switzerland (m/f/d) - based in Italy Applicants are expected to have a solid experience in handling Marketing – Product Marketing related tasks
Facilities HVAC Tech II Applicants are expected to have a solid experience in handling Operations – Facilities related tasks
Production Supervisor - Swing shift Applicants are expected to have a solid experience in handling Operations – Production related tasks
Facilities Technician I - Swing Applicants are expected to have a solid experience in handling Operations – Facilities related tasks
Associate Marketing Manager Applicants are expected to have a solid experience in handling Marketing – Product Marketing related tasks
Consignment Specialist (m/f/d) - based in Warsaw Applicants are expected to have a solid experience in handling Sales & Customer Support – Customer and Field Support Operations related tasks
remote-jobserver Remote
Marketing Manager Applicants are expected to have a solid experience in handling Sales & Customer Support – Sales Operations related tasks
Quality Engineer II - Electronics Applicants are expected to have a solid experience in handling Engineering – Quality Engineers related tasks
Manufacturing Engineer Intern - Temp Applicants are expected to have a solid experience in handling Engineering – Manufacturing Engineers related tasks
IT Specialist (m/f/d) - based in Warsaw Applicants are expected to have a solid experience in handling Information Technology – IT related tasks
remote-jobserver Remote
Vascular Product Marketing Manager EMEA (m/f/d) Applicants are expected to have a solid experience in handling Marketing – Product Marketing related tasks
HR Business Partner Applicants are expected to have a solid experience in handling Human Resources – Human Resources related tasks
R&D Engineer II - Embedded Firmware Applicants are expected to have a solid experience in handling Engineering – R&D related tasks
Medical Education Program Associate Applicants are expected to have a solid experience in handling Marketing – Medical Education related tasks
Accounts Receivable Specialist (Temporary Position) Applicants are expected to have a solid experience in handling General Administration – Finance & Accounting related tasks
remote-jobserver Remote
Therapy Development Specialist - Dallas, TX / Memphis, TN Applicants are expected to have a solid experience in handling Marketing – Product Marketing related tasks
Director of Manufacturing, Data Systems Applicants are expected to have a solid experience in handling Operations – Production related tasks
Inventory Control Coordinator I (Day Shift) Applicants are expected to have a solid experience in handling Operations – Logistics related tasks
Sales Ops Salesforce Business Analyst Applicants are expected to have a solid experience in handling Sales & Customer Support – Sales Operations related tasks
remote-jobserver Remote
Sales Manager Peripheral & Neurovascular Benelux (m/f/d) Applicants are expected to have a solid experience in handling Sales & Customer Support – International Sales related tasks
remote-jobserver Remote
Therapy Development Specialist - Carolinas / Washington, DC / Baltimore, MD Applicants are expected to have a solid experience in handling Marketing – Product Marketing related tasks
Procurement Portfolio Manager (Electronics Contract Manufacturing) Applicants are expected to have a solid experience in handling Procurement – Procurement related tasks