Medical Device Manufacturing Engineer II – Process & Quality

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

Benefits offered by this job

Medical coverage

Dental

Vision

401(k) with employer match

Parental leave

Paid vacation and holidays

Job summary

Penumbra, Inc. in Alameda, CA is seeking an engineering professional to independently perform detailed duties across product and process development.

You will solve complex problems, perform root cause analysis, and communicate solutions cross-functionally while supporting production and documentation in a qMS-regulated environment. The role emphasizes designing fixtures, qualifying equipment, and coordinating with suppliers to implement process improvements, with on-site work and potential

Qualifications

• Engineering degree with 1+ years of relevant engineering experience or equivalent
• Manufacturing environment experience preferred in medical device industry
• Strong written, verbal and interpersonal communication skills
• Proficiency in MS Word, Excel, PowerPoint, Access and related tools

Responsibilities

• Solve complex problems and implement innovative solutions.
• Perform root cause analysis and recommend vetted solutions.
• Communicate problems and solutions cross-functionally.
• Design fixtures and assist equipment qualification on production lines.
• Test processes, materials, and products; write test reports and conclusions.
• Plan and coordinate engineering work phases of projects.
• Develop product/process/equipment specifications.
• Coordinate with suppliers and external resources for process improvements.
• Train assemblers and technicians on processes and documentation.
• Adhere to QMS and applicable regulatory standards.

Skills

Complex problem solving

Root cause analysis

Cross-functional communication

Detail-oriented

Independent project recommendations

Production support

Documentation

Quality systems awareness

Process improvement

Education

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

Tools

Word

Excel

PowerPoint

Access

Job description

Penumbra, Inc. in Alameda, CA is seeking an engineering professional to independently perform detailed duties across product and process development.

You will solve complex problems, perform root cause analysis, and communicate solutions cross-functionally while supporting production and documentation in a qMS-regulated environment. The role emphasizes designing fixtures, qualifying equipment, and coordinating with suppliers to implement process improvements, with on-site work and potential