Senior Production Engineer – Medical Device Manufacturing

Beta Bionics, Inc.; Irvine (CA); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical + Dental

HSA/FSA

401(k) match

Paid time off

Job summary

The Senior Production Engineer at Beta Bionics, Inc. in Irvine, CA will design, develop and implement manufacturing processes that meet product specifications while ensuring safety, quality, and regulatory compliance.

You will monitor process performance, drive improvements, troubleshoot equipment, and collaborate with engineering, quality, maintenance and supply chain to hit production goals in a fast-growing startup environment.

Qualifications

• Bachelor's degree in mechanical/biomedical engineering or related field.
• 5–8 years of medical device experience.
• Experience in FDA/GMP/ISO environment.
• Ability to read mechanical drawings and electrical schematics.
• Proficient with Microsoft Office and related online applications.
• Ability to work effectively in cross-functional teams.

Responsibilities

• Support GMP and quality objectives, and comply with ISO 13485.
• Ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
• Develop process improvements to maximize production efficiency.
• Lead lean manufacturing initiatives.
• Troubleshoot equipment and use root cause analysis.
• Collaborate with engineering, quality, maintenance and supply chain.

Skills

QSRs/GMPs

Hand tools

Mechanical drawings

Electrical schematics

Microsoft Office

Cross-functional teamwork

Education

Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering or related field

Job description

The Senior Production Engineer at Beta Bionics, Inc. in Irvine, CA will design, develop and implement manufacturing processes that meet product specifications while ensuring safety, quality, and regulatory compliance.

You will monitor process performance, drive improvements, troubleshoot equipment, and collaborate with engineering, quality, maintenance and supply chain to hit production goals in a fast-growing startup environment.