Process Innovation Engineer I – Manufacturing

Penumbra, Inc.; Alameda (CA); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Parental leave

Company holidays

Vacation accrual

Paid sick time

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Development Manufacturing Engineering I to solve problems on the production line and drive process improvements.

You will design fixtures, perform equipment qualifications, and validate processes to support the manufacturing of innovative medical devices. The ideal candidate has a bachelor’s degree in engineering, 1+ year of relevant experience, and solid knowledge of FDA regulations, Lean manufacturing, and documentation practices.

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
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• 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

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 fixtures on the production line. Perform equipment qualifications.
• Test processes, equipment, raw materials, and products. 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.

Skills

Root cause analysis

Process improvement

Communication

Documentation

Equipment qualifications

Statistical techniques

FDA regulations knowledge

Office software

Education

Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering

Tools

Word

Excel

PowerPoint

Access

Job description

Penumbra, Inc. in Alameda, CA is seeking a Development Manufacturing Engineering I to solve problems on the production line and drive process improvements.

You will design fixtures, perform equipment qualifications, and validate processes to support the manufacturing of innovative medical devices. The ideal candidate has a bachelor’s degree in engineering, 1+ year of relevant experience, and solid knowledge of FDA regulations, Lean manufacturing, and documentation practices.