Manufacturing Engineer I - Metals

Summary: Penumbra is a global healthcare company focused on innovative therapies, and they are seeking a Manufacturing Engineer I to provide manufacturing technology and solutions for new products. The role involves problem-solving, process improvement, and collaboration with various engineering groups to enhance production efficiency. Responsibilities: - Solve problems and implement innovative solutions - Execute detailed root cause analysis and recommend vetted solutions - Communicate and explain problems and solutions cross-functionally and interdepartmentally - Approach problems from a detail-oriented perspective - Support production; Creating and maintaining product and process documentation; Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield, efficiency, and/or throughput - Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line. Perform equipment qualifications - 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 - 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 Required Qualifications: - Bachelor's degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree, or an equivalent combination of education and experience - 1+ year relevant engineering experience preferred - Excellent written, verbal and interpersonal communication skills required - Proficiency in Word, Excel, PowerPoint, Access and other computer applications required Preferred Qualifications: - Engineering experience in a manufacturing environment recommended, medical device industry preferred - Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired Required Skills: Manufacturing Engineering, Manufacturing Processes, Root Cause Analysis, Process Improvement, Fixture Design, Equipment Qualification, Process Validation, Statistical Techniques, Quality Management System (QMS), FDA Regulations, Lean Manufacturing, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access Benefits: 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, Paid sick time in compliance with applicable law(s)