Manufacturing Engineer III

$98,790 - $131,330/Yr

Penumbra - Roseville, CA

Full-time - Entry Level

Roseville, CA

Professional, Scientific, and Technical Services

About the position

The Manufacturing Engineering group at Penumbra, Inc. is dedicated to providing advanced manufacturing technology and robust solutions that facilitate the commercialization of new products while supporting continuous improvement in production processes. This role involves engaging in project opportunities that are designed to enhance professional skills, knowledge, and abilities, contributing to projects of global significance that are vital to the success of the business. The work primarily focuses on manufacturing processes, requiring collaboration with production teams and cross-departmental engineering groups to resolve challenges encountered on the production floor and throughout the organization. In this position, you will be tasked with solving complex problems and implementing innovative solutions. You will execute detailed root cause analyses and recommend vetted solutions, ensuring effective communication of problems and solutions across various functions and departments. A detail-oriented approach is essential as you will be expected to make independent recommendations regarding project approaches, scopes, and tactics. Your responsibilities will also include supporting production by creating and maintaining product and process documentation, monitoring process and equipment performance, and identifying opportunities for process improvement to enhance yield, efficiency, and throughput. You will demonstrate a comprehensive understanding of quality, operational, and financial systems, as well as the company's products and customer requirements, and how these elements impact the business objectives. Additionally, you will design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line. Your role will involve performing equipment qualifications, testing processes, equipment, raw materials, and products, and conducting process validations. You will author protocols for executing tests, write reports, and make conclusions or recommendations based on test results. Planning, scheduling, conducting, and coordinating detailed phases of engineering work will be part of your responsibilities, as will developing specifications for products, processes, or equipment. You will also develop, characterize, and optimize processes using statistical techniques and engineering knowledge, coordinating with suppliers and external resources as needed to implement process improvement plans. Training assemblers, quality control personnel, and technicians on processes, equipment, and documentation will be necessary, along with adhering to the Company's Quality Management System (QMS) and relevant regulations. You will ensure compliance with security, privacy, and compliance principles, and assist in ensuring that other department members follow the QMS and applicable regulations. Other duties may be assigned as required.

Responsibilities

• 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 interdepartmentally.
• Approach problems from a detail-oriented perspective.
• Suggest independent recommendations for project approach, scope, and tactics.
• Support production by 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.
• Demonstrate an understanding of quality, operational, and financial systems, company products and customer requirements.
• Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line.
• Perform equipment qualifications and process validations.
• Author protocols to execute tests, 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.
• Coordinate with 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 on processes, equipment, and documentation.
• Adhere to the Company's Quality Management System (QMS) and relevant regulations.

Requirements

• Bachelor's degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree.
• 2+ years relevant engineering experience, or an equivalent combination of education and experience.
• Engineering experience in a manufacturing environment recommended; medical device industry preferred.
• Excellent written, verbal, and interpersonal communication skills required; leadership skills desired.
• 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.

Nice-to-haves

• Experience in the medical device industry.
• Familiarity with Lean/Flow Manufacturing principles.

Benefits

• Medical, dental, vision, life, AD&D, short and long-term disability insurance.
• 401(k) with employer match.
• 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.
• Paid sick time in compliance with applicable law(s).