Manufacturing Engineer II (Medical Device | QMS & Supplier Quality)

General SummaryAs 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 commercializing new products and 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.What You'll Work On•Solve complex problems and implement innovative solutions•Execute detailed root cause analysis and recommend vetted solutions•Communicate and explain problems and solutions cross-functionally and inter-departmentally•Collaborate closely with suppliers, ensure timely communication of updates, and respectfully request any necessary changes.•Manage NCRs, deviations, engineering change orders, and supplier documentation while utilizing a Quality Management System to ensure continuous improvement and compliance.•Engage in the troubleshooting of electromechanical products by employing failure analysis and problem-solving techniques, while also recommending and implementing effective solutions.•Lead the implementation of projects at the supplier level, managing communications related to test plans, monitoring project timelines, and ensuring all milestones are met efficiently.•Approach problems from a detail-oriented perspective•Suggest independent recommendations for project approach, scope, and tactics•Support production needs•Create and maintain product and process documentation•Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield•Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line•Test processes, equipment, raw materials, and product•Perform process validations•Author protocols to execute tests and write reports and make conclusions and/or recommendations based on test results•Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project•Develop specifications of a product, process, or piece of equipment•Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience•Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans•Participate in project planning and scheduling•Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation•Comply with quality system regulations, standards and procedures* Indicates an essential function of the roleLocation and Pay•Alameda, CA•$95,000 to $127,000Position QualificationsMinimum education and experience:•Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree with 2+ years relevant engineering experience, or an equivalent combination of education and experienceAdditional qualifications:•Engineering experience in a manufacturing environment recommended, medical device industry preferred•Experience in troubleshooting and working with electromechanical devices•Excellent written, verbal, and interpersonal communication skills required•Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired•Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required•Supplier audits, risk management (FMEA, DFMEA, PFMEA), lean manufacturing/six sigma, equipment qualificationWorking Conditions•General office, laboratory, and clean room environments.•Willingness and ability to work on site.•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.