Supplier Development Engineer II — Lean Process Innovator

BD; Irvine (CA); On-site; USD 84,000 - 134,000; Full time

Benefits offered by this job

Total Rewards program

Competitive compensation

Job summary

BD in Irvine seeks a manufacturing/process engineer to optimize production, drive Six Sigma/LEAN initiatives, and lead validation activities for process improvements. You will work with internal teams and suppliers to ensure quality, compliance, and efficient operations on the shop floor.

The role requires strong problem-solving, documentation, and project-management skills, with a focus on manufacturability and regulatory compliance in a fast-paced environment.

Qualifications

• Proven expertise using MS Office Suite and MS Project for project tracking.
• CAD experience preferred; ability to read/modify 2D/3D drawings for manufacturability.
• Strong documentation, communication, and interpersonal skills required.
• Basic understanding of regulatory requirements for medical devices (FDA).

Responsibilities

• Lead identification and implementation of manufacturing process improvements using Six Sigma and LEAN methods.
• Plan and execute experiments and tests; analyze results and generate reports.
• Collaborate with suppliers and internal teams on process development and validation.
• Develop qualification plans and documentation; manage project plans and risks.
• Address manufacturing and compliance issues (CAPA, non-conformances, audits).
• Prepare training materials and work instructions for production.

Skills

MS Office

MS Project

CAD

Documentation

Statistical methods

Cross-functional collaboration

Education

Bachelor's in engineering

Master's in Engineering

Tools

CAD software

Project management software

Job description

BD in Irvine seeks a manufacturing/process engineer to optimize production, drive Six Sigma/LEAN initiatives, and lead validation activities for process improvements. You will work with internal teams and suppliers to ensure quality, compliance, and efficient operations on the shop floor.

The role requires strong problem-solving, documentation, and project-management skills, with a focus on manufacturability and regulatory compliance in a fast-paced environment.