Metals Manufacturing Engineer II: Optimize & Innovate

Penumbra, Inc.; Alameda (CA); On-site; USD 95,000 - 127,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Paid parental leave

Vacation accrual

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Manufacturing Engineer to develop and implement manufacturing solutions, perform root-cause analysis, and support production with process improvements.

You will design fixtures, qualify equipment, and ensure adherence to quality and regulatory standards. The role requires a degree in engineering and 1+ years in a manufacturing setting; excellent communication and problem-solving skills are essential.

Qualifications

• Bachelor’s degree in engineering with 1+ years relevant experience.
• 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.

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 approaches, scope, and tactics.
• Support production; create and maintain 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.
• 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, 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.
• Perform other work‑related duties as assigned.
• 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

Lean manufacturing

Communication skills

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 Manufacturing Engineer to develop and implement manufacturing solutions, perform root-cause analysis, and support production with process improvements.

You will design fixtures, qualify equipment, and ensure adherence to quality and regulatory standards. The role requires a degree in engineering and 1+ years in a manufacturing setting; excellent communication and problem-solving skills are essential.