Staff Supplier Engineer, Robotics & MedTech Manufacturing

jj; Santa Clara (CA); On-site; USD 118,000 - 204,000; Full time

Job summary

Johnson & Johnson in Santa Clara, CA is seeking a Staff Supplier Engineer to design, develop, and validate manufacturing solutions for direct material components and assemblies within the Robotics & Digital Solutions group.

This role requires at least seven years of experience in a regulated medical device environment, GD&T proficiency, supplier management, and up to 25% travel. Mentorship of junior engineers and scale-up of robust processes are key aspects.

Qualifications

• BS degree is required, preferably in Engineering or similar.
• Minimum of seven (7) years of meaningful work experience in a regulated industry (medical device industry preferred).
• Validated knowledge of various component/assembly manufacturing process development and production validation.
• Understanding of engineering drawing interpretation, i.e., GD&T required.
• Mechatronics and robotics experience, preferred.
• Solid understanding of quality requirements/documents such as statistical process control, capability analysis, FMEA’s, etc., preferred.
• Understanding of product design & DFM/A (Design for Manufacturing & Assembly), preferred.
• Experience with supplier management, supplier qualification/selection, and process improvement with suppliers.
• Root cause analysis, preferred.
• Understanding of Six Sigma Methodologies, preferred.
• Excellent knowledge of 21 CFR part 820 and ISO 13485
• Solid understanding of regulatory requirements regarding the design, manufacture, and release of medical devices, worldwide, preferred
• Up to 25% domestic and international travel required.

Responsibilities

• Own the development, characterization, and validation of plastics components and sub-assembly processes at suppliers for new product development (NPD) projects and sustaining production within the Robotics and Digital Solutions franchise.
• Lead the scale-up of supplier manufacturing processes to production quantities.
• Work in a design team setting, collaborating with multi-functional teams by providing technical solutions to direct material component manufacturing and assembly processes that are optimized for manufacturing, product performance, and cost.
• Apply engineering principles, world-class manufacturing techniques, statistics, and risk management to resolve complex technical challenges.
• Identify, manage, and provide priorities and direction to external suppliers to satisfy manufacturing and development requirements for tooling, manufacturing, and inspections of direct material components.
• Responsible for ensuring robust requirements cascade from Design to Suppliers.
• Drive suppliers to continually improve their business and manufacturing process performance to meet business requirements for supplier excellence using Six Sigma, Lean, SPC and negotiation.
• Support corrective actions for supplier process by driving root-cause analysis and corrective and Preventive actions.
• Coordinate project activities and maintain accountability for overall project success.
• Other duties as required

Skills

Mechatronics and robotics experience

Root cause analysis

Quality systems knowledge

Education

BS degree in Engineering or similar

Tools

GD&T

FMEA

SPC

Job description

Johnson & Johnson in Santa Clara, CA is seeking a Staff Supplier Engineer to design, develop, and validate manufacturing solutions for direct material components and assemblies within the Robotics & Digital Solutions group.

This role requires at least seven years of experience in a regulated medical device environment, GD&T proficiency, supplier management, and up to 25% travel. Mentorship of junior engineers and scale-up of robust processes are key aspects.