Staff Manufacturing Engineer

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

Senior/Staff Manufacturing Engineer

The Senior/Staff Manufacturing Engineer & Operations Supervisor supports heart valve manufacturing operations through process development, validation, continuous improvement, equipment/tooling development, and production support. This role also provides direct leadership for a team of up to six production associates and specialists.

Responsibilities span the full heart valve manufacturing process, including tissue inspection, solution preparation, laser processing, valve assembly, packaging, sterilization, and labeling.

Key Responsibilities

Manufacturing Engineering

• Support development and manufacturing of implantable heart valve products.
• Partner with R&D, Quality, Clinical, and Regulatory teams throughout product development and commercialization.
• Develop, execute, and maintain process validations.
• Lead process optimization efforts to improve quality, efficiency, and production performance.
• Design and implement tooling, fixtures, and manufacturing equipment improvements.
• Manage manufacturing transfer and scale-up activities.

Production & Quality Support

• Lead investigations, nonconformance activities, and CAPA initiatives.
• Support calibration and maintenance programs for manufacturing equipment.
• Develop and maintain manufacturing procedures, work instructions, validation protocols, and technical reports.
• Participate in Material Review Board (MRB) activities and product disposition decisions.

Team Leadership

• Ensure compliance with FDA, OSHA, and internal quality requirements for Class III medical devices.
• Manage employee performance, training, and development.
• Support a safe, efficient, and compliant manufacturing environment.
• Drive production objectives related to quality, yield, throughput, and cost.
• Lead production meetings and facilitate cross-functional communication.

Qualifications

• Bachelor's degree in Engineering; Mechanical Engineering preferred.
• 4+ years of experience in FDA-regulated manufacturing environments.
• Prior supervisory or team leadership experience preferred.
• Experience with heart valve manufacturing, cardiovascular implants, Class III medical devices, pharmaceutical, or aerospace industries strongly preferred.
• Strong background in process validation, DOE, statistical analysis, root cause investigation, CAPA, and continuous improvement methodologies.
• Excellent technical writing, project management, and cross-functional collaboration skills.
• Hands-on problem solver with the ability to drive results in a manufacturing environment.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.