Strategic Supplier Development Engineer

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

Job summary

BD Irvine, CA site seeks a manufacturing engineer with 4+ years of experience to drive process improvements in a medical device environment. Lead DOE studies, qualify processes, and coordinate IQ/OQ/PQ validations with suppliers. Strong problem solving and leadership needed.

Requires a Bachelor's in Engineering; Master’s beneficial. You will train staff, develop inspection methods, and collaborate with Regulatory, Quality, Supply Chain, and R&D to ensure robust manufacturing and compliant

Qualifications

• Bachelor's degree in Engineering is required.
• 4+ years of relevant engineering experience with a Bachelor's.
• 3+ years of relevant engineering experience with a Master's.
• Experience with manufacturing processes and Six Sigma / LEAN.
• Knowledge of statistical techniques.
• Experience with DOE and process validation.
• Experience working with suppliers and external partners.
• Knowledge of FDA regulations for medical devices.
• Strong documentation and communication skills.
• Ability to collaborate across functions.

Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using Six Sigma/LEAN methods.
• Develop and manage complex experiments to qualify and validate processes; analyze results.
• Collaborate with suppliers on process development and validation (IQ/OQ/PQ/TMVs).
• Initiate and execute part qualification plans and reports.
• Train and coach lower-level staff on complex procedures.
• Oversee manufacturing support tasks and coordinate engineer/technician work.
• Lead complex project plans to meet customer expectations with PM tools.
• Address Manufacturing and Compliance issues (CAPA, non-conformances, audits).
• Lead supplier notifications for changes (NOCs) and EOL components.
• Develop training and documentation for production to transfer knowledge.
• Collaborate with Regulatory, Quality, Supply Chain, and R&D.
• Identify equipment and inspection methods; perform Gauge Studies and analytics.
• Read/interpet 2D drawings & 3D CAD to aid manufacturability.
• Demonstrate structured problem-solving for technical/logistical issues.
• Perform other incidental duties.

Skills

Project management

Leadership

Problem solving

DOE

Communication

Analytical thinking

Education

Bachelor's Degree in Engineering

Master's degree beneficial

Tools

CAD

MS Project

MS Office

Job description

BD Irvine, CA site seeks a manufacturing engineer with 4+ years of experience to drive process improvements in a medical device environment. Lead DOE studies, qualify processes, and coordinate IQ/OQ/PQ validations with suppliers. Strong problem solving and leadership needed.

Requires a Bachelor's in Engineering; Master’s beneficial. You will train staff, develop inspection methods, and collaborate with Regulatory, Quality, Supply Chain, and R&D to ensure robust manufacturing and compliant