Development Mfg Engineer I – Process Innovation & Equity

Penumbrainc; Alameda (CA); On-site; USD 80,000 - 105,000; 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

Paid vacation and sick time

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Development Manufacturing Engineer to design and improve production processes, fixtures, and equipment while ensuring compliance with QMS and FDA-related practices.

The role involves cross-functional collaboration, root-cause analysis, and detailed documentation to optimize yield and throughput. Responsibilities include developing process specifications, performing validations, coordinating supplier resources, and training production staff.

Qualifications

• 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.

Education

Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree, or an equivalent combination of education and experience

Job description

Penumbra, Inc. in Alameda, CA is seeking a Development Manufacturing Engineer to design and improve production processes, fixtures, and equipment while ensuring compliance with QMS and FDA-related practices.

The role involves cross-functional collaboration, root-cause analysis, and detailed documentation to optimize yield and throughput. Responsibilities include developing process specifications, performing validations, coordinating supplier resources, and training production staff.