Manufacturing Engineer I — Medical Device Innovator

Penumbra, Inc.; Roseville (CA); On-site; USD 72,000 - 94,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D

Disability insurance

401(k) with employer match

Paid parental leave

eleven paid company holidays per year

Vacation accrual

Job summary

Penumbra, Inc. is seeking a Manufacturing Engineer to support the production floor with problem solving, process improvements, and equipment qualifications.

You will develop fixtures, validate processes, and create documentation to ensure high yield and quality. The role emphasizes detailed problem solving, cross-functional communication, and adherence to QMS and regulatory requirements, with on-site work in California.

Qualifications

• Bachelor’s degree or equivalent in engineering.
• 1+ year relevant engineering experience preferred.
• Manufacturing environment experience recommended; medical device industry preferred.
• Excellent written, verbal, and interpersonal communication skills.
• 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; create and maintain product and process documentation; monitor process and equipment performance and identify/improve yield, efficiency, throughput.
• Design fixtures, acquire tooling/equipment, implement fixtures on production line; perform equipment qualifications.
• Test processes, equipment, materials, and products; perform process validations; author protocols and write reports.
• Plan, schedule, conduct, and coordinate phases of engineering work as part of a project.
• Develop specifications of products, processes, or equipment.
• Develop, characterize, and optimize processes using statistical techniques and engineering knowledge.
• Coordinate with suppliers/external resources for process improvements.
• Participate in project planning and scheduling.
• Train assemblers, quality control and technicians on processes, equipment, and documentation.
• Adhere to QMS and applicable regulations and procedures in quality systems.
• Ensure compliance with security, privacy, and regulatory requirements.

Skills

Engineering experience

Manufacturing environment

Communication skills

Lean/Flow Manufacturing

Medical device industry knowledge

Education

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

Tools

MS Office Suite

Job description

Penumbra, Inc. is seeking a Manufacturing Engineer to support the production floor with problem solving, process improvements, and equipment qualifications.

You will develop fixtures, validate processes, and create documentation to ensure high yield and quality. The role emphasizes detailed problem solving, cross-functional communication, and adherence to QMS and regulatory requirements, with on-site work in California.