Senior Medical-Device Manufacturing Engineer

Lehigh Heavy Forge Corporation; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD is a leading global medical technology company focused on advancing health. The Manufacturing Engineer will support and improve manufacturing operations by developing, qualifying, implementing, and optimizing processes, equipment, and methods in an FDA-regulated environment.

The role collaborates with Quality Assurance, R&D, and Operations to enable new product introductions, process validations, and continuous improvement while maintaining high standards for quality and compliance.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering or related field.
• FDA-regulated manufacturing environment experience preferred.
• Strong written and verbal communication skills.
• Experience documenting technical processes and procedures.

Responsibilities

• Establish and maintain manufacturing documentation, procedures, drawings, and records.
• Develop and optimize manufacturing processes and tooling.
• Lead transfer of new products from R&D to manufacturing.
• Train operators on processes, equipment, and procedures.
• Coordinate qualifications (IQ/OQ/PQ) and CAPA activities.

Skills

Fluent English communication

Technical writing

Education

Bachelor's degree in Mechanical Engineering

Master's degree in Mechanical Engineering

Tools

SolidWorks

Microsoft Project

Job description

BD is a leading global medical technology company focused on advancing health. The Manufacturing Engineer will support and improve manufacturing operations by developing, qualifying, implementing, and optimizing processes, equipment, and methods in an FDA-regulated environment.

The role collaborates with Quality Assurance, R&D, and Operations to enable new product introductions, process validations, and continuous improvement while maintaining high standards for quality and compliance.