Senior Supplier Development Engineer: Process Excellence

BD; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD in USA CA - Irvine Laguna Canyon is seeking a skilled Manufacturing Engineer to optimize manufacturing processes, develop and validate processes, and collaborate with suppliers. The role requires a Bachelor’s Degree in Engineering and 4+ years of relevant experience, with CAD proficiency and a solid grounding in quality systems.

Responsibilities include leading experiments, integrating DoE, and driving project plans to meet customer expectations while ensuring compliance with regulatory

Qualifications

• Bachelor’s degree in Engineering required.
• Biomedical or Mechanical Engineering preferred.
• Strong documentation, communication, and interpersonal skills.
• Experience with DoE and statistical analysis helpful.
• Familiarity with FDA regulations for medical devices helpful.

Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using engineering methods (e.g., Six Sigma, LEAN).
• Develop and execute complex experiments and tests; write and analyze protocols and reports.
• Collaborate with suppliers on process development and validation (IQ/OQ/PQ/TMVs).
• Initiate part qualification plans and reports.
• Train and guide junior engineers and technicians; oversee testing activities.
• Lead complex project plans to meet customer expectations using project management tools.
• Analyze and resolve manufacturing and compliance issues (CAPA, non-conformances, audits).

Education

Bachelor’s Degree in Engineering

Tools

CAD

Job description

BD in USA CA - Irvine Laguna Canyon is seeking a skilled Manufacturing Engineer to optimize manufacturing processes, develop and validate processes, and collaborate with suppliers. The role requires a Bachelor’s Degree in Engineering and 4+ years of relevant experience, with CAD proficiency and a solid grounding in quality systems.

Responsibilities include leading experiments, integrating DoE, and driving project plans to meet customer expectations while ensuring compliance with regulatory