Senior Medical Device Automation Engineer

Beta Bionics, Inc.; Irvine (CA); On-site; USD 115,000 - 145,000; Full time

Benefits offered by this job

Comprehensive medical and dental coverage

401(k) program with employer match

Generous vacation accrual

Job summary

Beta Bionics, Inc. seeks a Senior Manufacturing Automation Engineer in Irvine, California. This pivotal role involves leading automation initiatives in a regulated medical device environment to enhance safety, quality, and production efficiency. Candidates should have at least 7 years of relevant experience, a degree in engineering, and technical skills in automation. Benefits include comprehensive health coverage, a 401(k) program, and generous vacation policies. The salary ranges from $115,000 to $145,000, depending on experience.

Qualifications

• 7+ years of experience in automation or manufacturing engineering in a regulated medical device environment.
• Experience owning manufacturing equipment through installation and qualification.
• Familiarity with FDA regulations, GMP, ISO 13485, and risk management.

Responsibilities

• Own assigned manufacturing equipment through its lifecycle.
• Author User Requirements Specifications and supporting documentation.
• Independently design mechanical improvements to enhance safety and quality.

Skills

Troubleshooting

Technical writing

Project management

Cross-functional communication

Education

Bachelor’s degree in Mechanical, Manufacturing, Electrical, Mechatronics, or related engineering discipline

Tools

SolidWorks

Job description

Beta Bionics, Inc. seeks a Senior Manufacturing Automation Engineer in Irvine, California. This pivotal role involves leading automation initiatives in a regulated medical device environment to enhance safety, quality, and production efficiency. Candidates should have at least 7 years of relevant experience, a degree in engineering, and technical skills in automation. Benefits include comprehensive health coverage, a 401(k) program, and generous vacation policies. The salary ranges from $115,000 to $145,000, depending on experience.