Supplier Development Engineer II - Lean Process Innovator

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

Job summary

BD in Irvine, CA seeks a Manufacturing/Process Engineer to optimize manufacturing processes, run experiments, and qualify methods. You will collaborate with suppliers, handle CAPA and regulatory readiness, and review 2D/3D drawings for manufacturability.

Requires a Bachelor's in engineering and 3 years’ experience; Master’s preferred. Proficiency with MS Office, MS Project, and CAD tools is valued. A cross-functional, growth-oriented environment is offered.

Qualifications

• Proven expertise with MS Office including MS Project.
• Strong documentation and communication skills.
• Basic understanding of statistical techniques.
• Experience with lab/industrial equipment is a plus.
• Knowledge of FDA regulations for medical devices.

Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using engineering methods.
• Design and execute experiments, write protocols, analyze results and create reports.
• Collaborate with suppliers on process development and validation (IQ/OQ/PQ/TMVs).
• Initiate and execute part qualification plans and reports.
• Develop project plans and manage deliverables to customer expectations.

Skills

MS Office

MS Project

CAD experience

Statistical techniques

Education

Bachelor's in Engineering

Master's degree

Tools

CAD software

Job description

BD in Irvine, CA seeks a Manufacturing/Process Engineer to optimize manufacturing processes, run experiments, and qualify methods. You will collaborate with suppliers, handle CAPA and regulatory readiness, and review 2D/3D drawings for manufacturability.

Requires a Bachelor's in engineering and 3 years’ experience; Master’s preferred. Proficiency with MS Office, MS Project, and CAD tools is valued. A cross-functional, growth-oriented environment is offered.