Staff Manufacturing Engineer, Heart Valve Operations Lead

Real Staffing; Irvine (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Real Staffing is seeking a Senior/Staff Manufacturing Engineer to support heart valve manufacturing operations, including process development, validation, and leadership of a small production team. The role spans tissue inspection, laser processing, assembly, packaging, sterilization, and labeling.

The candidate will collaborate with R&D, Quality, Clinical, and Regulatory teams to drive process validations, continuous improvement, and successful product commercialization for Class III medical

Qualifications

• Bachelor's degree in Engineering required; Mechanical Engineering preferred.
• 4+ years in FDA-regulated manufacturing environments.
• Prior supervisory or team leadership experience preferred.
• Experience with heart valve manufacturing or Class III medical devices is strongly preferred.
• Strong background in process validation, DOE, statistical analysis, CAPA, and continuous improvement.

Responsibilities

• Support development and manufacturing of implantable heart valve products.
• Partner with R&D, Quality, Clinical, and Regulatory teams throughout development and commercialization.
• Develop, execute, and maintain process validations.
• Lead process optimization to improve quality, efficiency, and throughput.
• Design and implement tooling, fixtures, and equipment improvements.
• Manage manufacturing transfer and scale-up activities.
• Lead investigations, CAPA, and MRB activities.
• Develop and maintain manufacturing procedures and validation protocols.
• Ensure compliance with FDA/OSHA requirements for Class III devices.

Skills

Process validation

DOE

Statistical analysis

Root cause investigation

CAPA

Continuous improvement

Technical writing

Project management

Cross-functional collaboration

Hands-on problem solving

Education

Bachelor's degree in Engineering

Mechanical Engineering preferred

Tools

None

Job description

Real Staffing is seeking a Senior/Staff Manufacturing Engineer to support heart valve manufacturing operations, including process development, validation, and leadership of a small production team. The role spans tissue inspection, laser processing, assembly, packaging, sterilization, and labeling.

The candidate will collaborate with R&D, Quality, Clinical, and Regulatory teams to drive process validations, continuous improvement, and successful product commercialization for Class III medical