Manufacturing Engineer III

Penumbra • Alameda, CA

6d • Onsite

About The Position

The Manufacturing Engineering group's mission is to provide manufacturing technology and robust solutions for commercializing new products and supporting continuous improvement in production. This role involves developing professional work, knowledge, and abilities through projects of global importance to the business. The work focuses on manufacturing processes, interacting with production and cross-departmental engineering groups to resolve problems on the production floor and across the business. The role coordinates the evaluation, selection, and application of engineering techniques, procedures, and criteria, using independent judgment to adapt and modify production lines and quality systems.

Requirements

• Bachelor's degree in Electrical, Biomedical, Mechanical, Chemical, Materials, or Industrial Engineering or related degree with 4+ years relevant engineering experience, or an equivalent combination of education and experience
• Excellent written, verbal, and interpersonal communication skills required
• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required

Nice To Haves

• Engineering experience in a manufacturing environment recommended
• Medical device industry preferred
• Leadership skills desired
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired

Responsibilities

• Design, execute and document test plans for qualification of PCBA components
• 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
• Solve complex problems and implement innovative solutions
• 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
• Demonstrate an understanding of quality, operational, and financial systems, company products and customer requirements and how the product or project impacts the objectives of the business
• Demonstrate an understanding of how other functional groups within the company are impacted by projects at hand and can impact the project or product results
• Test processes, equipment, raw materials, and product
• Perform 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, 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

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior