Manufacturing Engineer II

The Manufacturing Engineer II (ME II) will support the development of manufacturing and assembly processes for a rotary total artificial heart, incorporating value engineering techniques.

This role works closely with management, internal teams, and vendors to improve tooling, quality, and cost efficiency. The ME II optimises device design and manufacturing processes to produce implantable components that meet specifications reliably.

Located in Long Beach, CA, we seek a hands-on candidate with strong communication, organisational, problem-solving, and technical skills. National and international travel may be required.

Responsibilities

• Review and improve manufacturing processes with vendors.
• Develop and validate processes from prototype to product, including equipment design and validation.
• Define product output specifications and create work instructions.
• Manage design transfer to manufacturing and verify processes, including statistical control and material traceability.
• Support regulatory submissions and participate in failure analysis/corrective actions.
• Conduct risk analysis and manage supplier relationships.

Requirements

• BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering (MS desirable).
• 3–5 years of experience in product and process development, preferably in medical devices.
• Knowledge of process characterization, pFMEAs, MVP, IQ/OQ/PQ, and TMVs.
• Familiarity with ISO 13485, FDA regulations, and industry standards.
• Experience in logistics and supply chain management is a plus.