Junior Manufacturing Process Engineer – Medical Devices

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

Benefits offered by this job

Medical, dental, vision insurance

Life and disability insurance

401(k) with employer match

Paid parental leave

Holidays and vacation

Job summary

Penumbra, Inc. in Alameda, CA is seeking an Development Manufacturing Engineer I to evaluate, select, and apply manufacturing techniques on the production line and to quality systems.

The role emphasizes problem solving, process improvement, and cross-functional collaboration to support scalable manufacturing of devices. The position requires a Bachelor’s degree in engineering and 1+ year of relevant experience, with knowledge of FDA regulations and Lean manufacturing.

Qualifications

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

Cross-functional communication

Process improvement

Education

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

Tools

Word

Excel

PowerPoint

Access

Job description

Penumbra, Inc. in Alameda, CA is seeking an Development Manufacturing Engineer I to evaluate, select, and apply manufacturing techniques on the production line and to quality systems.

The role emphasizes problem solving, process improvement, and cross-functional collaboration to support scalable manufacturing of devices. The position requires a Bachelor’s degree in engineering and 1+ year of relevant experience, with knowledge of FDA regulations and Lean manufacturing.