Manufacturing Engineer II, Intravascular Lithotripsy (IVL)

Johnson Johnson; Santa Clara (CA); On-site; USD 73,000 - 117,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, vision insurance

401(k) savings plan

Paid time off – up to 120 hours

Job summary

Johnson & Johnson is hiring a Manufacturing Engineer II in Santa Clara, CA to support Production with process/tooling development and validation for cutting‑edge intravascular therapies. The role emphasizes reliability, quality compliance, and cross‑functional collaboration in a fast‑paced environment.

The position requires 3–5 years in medical devices, Lean Six Sigma knowledge, and hands‑on experience with IQ‑OQ‑PQ validations and SolidWorks drawings.

Qualifications

• Bachelor's degree in engineering.
• 3–5 years of experience in a medical device environment.
• Knowledge of and compliance with QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Statistics basics (Cpk, Hypothesis Testing, DOE, Gage R&R).
• Ability to create and maintain Drawings in SolidWorks.
• MES and ERP (Oracle) experience preferred.

Responsibilities

• Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
• Identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
• Coordinate and/or perform functional and destructive testing and analyze results.
• Support new product introduction including scaling up, stabilizing and transfer to alternate sites.
• Develop and maintain process FMEAs, MPIs, and DMR documents.
• Create, maintain and transfer BOMs and LHRs into item structures and definitions.
• Create and release label files for product labels.
• Create and execute process validation protocols and reports.
• Support Quality events (NCR, CAPA, Audit Finding) and related documentation.

Skills

Teamwork

Adaptability

Problem solving

Multitasking

Education

Bachelor's degree in engineering

Tools

SolidWorks

MES

ERP (Oracle)

Job description

Johnson & Johnson is hiring a Manufacturing Engineer II in Santa Clara, CA to support Production with process/tooling development and validation for cutting‑edge intravascular therapies. The role emphasizes reliability, quality compliance, and cross‑functional collaboration in a fast‑paced environment.

The position requires 3–5 years in medical devices, Lean Six Sigma knowledge, and hands‑on experience with IQ‑OQ‑PQ validations and SolidWorks drawings.