Manufacturing Engineer I

$80,330 - $104,780/Yr

Penumbra - Alameda, CA

Full-time - Entry Level

Alameda, CA

Professional, Scientific, and Technical Services

About the position

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 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. Your engineering knowledge and creativity will be essential in implementing adaptations and modifications to the production line and quality systems. In this role, you will engage in detailed root cause analysis and recommend vetted solutions. You will communicate and explain problems and solutions across various departments, approaching issues from a detail-oriented perspective. Your responsibilities will include suggesting independent recommendations for project approaches, scopes, and tactics, as well as supporting production needs. You will create and maintain product and process documentation, monitor process and equipment performance, and identify and implement process improvement activities to increase yield. You will also design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line. Testing processes, equipment, raw materials, and products will be part of your duties, along with performing process validations. You will author protocols to execute tests, write reports, and make conclusions or recommendations based on test results. Planning, scheduling, conducting, and coordinating detailed phases of engineering work will be essential, as will developing specifications for products, processes, or equipment. You will characterize and optimize processes using statistical techniques and engineering knowledge, coordinate with suppliers and external resources, and participate in project planning and scheduling. Training assemblers, quality control personnel, and technicians on processes, equipment, and documentation will also be part of your role. Compliance with quality system regulations, standards, and procedures is crucial, as is ensuring that other department members adhere to the Quality Management System (QMS).

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 inter-departmentally
• 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
• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
• Ensure other members of the department follow the QMS, regulations, standards and procedures
• Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects.

Requirements

• BS degree in Mechanical, Biomedical, Chemical, or Materials Engineering, or a related discipline required
• Proven knowledge of FDA regulations, lean manufacturing, and/or materials and manufacturing processes preferred
• Medical device experience strongly preferred
• Proven track record of solving problems creatively preferred
• The ability to communicate complex issues in a clear, compelling manner, both orally and in writing preferred
• A passion for tackling and solving technical problems preferred
• Proven work history of growing within an organization, learning its systems, and showing initiative preferred

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)