Sterilization Engineering Lead

B. Braun Medical Inc. (US); Irvine (CA); On-site; USD 126,000 - 157,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Irvine is seeking a Sr. Engineering Specialist to lead sterilization initiatives within a regulated medical device environment. You will partner with Manufacturing, Quality, Validation, and Maintenance to optimize spectrum of sterilization processes and maintain GMP-compliant documentation.

The role focuses on terminal steam sterilization, aseptic processing, and process validation, with opportunities to drive continuous improvement across engineering projects.

Qualifications

• Bachelor's degree in Chemical, Mechanical, Biomedical, or related Engineering.
• 10+ years of engineering experience in a regulated manufacturing environment.
• Experience supporting sterilization, manufacturing, or process equipment.
• Strong knowledge of GMPs, validation, change control, and engineering documentation practices.
• Demonstrated troubleshooting, project management, and problem-solving skills.
• Strong communication and collaboration skills.

Responsibilities

• Serve as the site SME for sterilization processes and related equipment.
• Support and improve terminal steam sterilization systems and manufacturing operations.
• Troubleshoot equipment and process issues, identify root causes, and implement sustainable solutions.
• Support commissioning, qualification, validation, and change control activities.
• Lead and support engineering projects focused on reliability, compliance, efficiency, and business continuity.
• Develop and maintain technical documentation, procedures, and engineering records.
• Partner with cross-functional teams to drive operational excellence and continuous improvement initiatives.

Skills

GMP knowledge

Validation experience

Change control

Troubleshooting

Project management

Communication

Collaboration

Education

Bachelor's degree in Chemical/Mechanical/Biomedical Engineering

Tools

Engineering documentation systems

Job description

B. Braun Medical Inc. in Irvine is seeking a Sr. Engineering Specialist to lead sterilization initiatives within a regulated medical device environment. You will partner with Manufacturing, Quality, Validation, and Maintenance to optimize spectrum of sterilization processes and maintain GMP-compliant documentation.

The role focuses on terminal steam sterilization, aseptic processing, and process validation, with opportunities to drive continuous improvement across engineering projects.