Manufacturing Process Engineer – Medical Devices

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 insurance

Disability insurance

401(k) with employer match

Paid parental leave

11 holidays per year

15 days paid vacation per year

Paid sick time

Job summary

Penumbra, Inc. in Roseville, CA, is seeking a Manufacturing Engineer to drive manufacturing technology, improve production yield, and support quality systems across the production floor.

You will resolve production issues, design fixtures, run process validations, and train staff while aligning with QMS and FDA-related standards. The role requires a bachelor’s degree in engineering and preferred 1+ year of manufacturing experience, with strong communication skills and proficiency in common

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree.
• 1+ year engineering experience in manufacturing preferred.
• Experience in the medical device industry preferred.
• Excellent written, verbal and interpersonal communication skills.
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and materials/manufacturing processes desired.
• Proficiency in Word, Excel, PowerPoint, Access and other computer applications required.

Responsibilities

• Solve problems and implement innovative solutions on the production line.
• Execute root cause analysis and recommend vetted solutions.
• Communicate problems and solutions cross-functionally.
• Improve yield, efficiency, and throughput through process improvements.
• Design fixtures, acquire tooling, and implement new fixturing; perform equipment qualifications.
• Test processes, equipment, materials, and product; perform process validations and write reports.
• Plan and coordinate detailed phases of engineering work on projects.
• Develop specifications for products, processes, or equipment.
• Characterize and optimize processes using statistical techniques.
• Coordinate with suppliers and resources for process improvement plans.
• Train assemblers, QA and technicians on processes, equipment and documentation.
• Adhere to QMS and applicable quality regulations and procedures.
• Follow security, privacy and compliance principles.
• Perform other duties as assigned.

Job description

Penumbra, Inc. in Roseville, CA, is seeking a Manufacturing Engineer to drive manufacturing technology, improve production yield, and support quality systems across the production floor.

You will resolve production issues, design fixtures, run process validations, and train staff while aligning with QMS and FDA-related standards. The role requires a bachelor’s degree in engineering and preferred 1+ year of manufacturing experience, with strong communication skills and proficiency in common