NPI Engineer II: MedTech Process Innovator

6947-SHOCKWAVE MEDICAL INC. Legal Entity

Santa Clara (CA)

On-site

USD 87,000 - 140,300

Full time

14 days+

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Benefits offered by this job

401(k) plan

Long-term incentive program

Vacation accrual

Job summary

Johnson & Johnson in Santa Clara, CA, is hiring an NPI Engineer II to advance intravascular lithotripsy (IVL) product development and support transition from development to production. You will work with research, operations, regulatory, and quality teams to optimize processes and ensure readiness for manufacturing.

The role emphasizes process development, pilot manufacturing oversight, and sustaining activities on the production line while solving complex technical issues in a fast-paced

Qualifications

Bachelor’s degree in Mechanical or Biomedical Engineering.
3+ years in a medical device environment.
Knowledge of QSRs, FDA, ISO, MDD/MDR and related regulations.

Responsibilities

Actively collaborate with Production to provide sustaining support for product/process/issues.
Participate in process FMEAs, MPIs, and DMR documentation.
Create, validate, and release label files for product labels.
Develop and execute process validation protocols and reports.

Skills

Medical device development

Lean Six Sigma

Validation IQ-OQ-PQ

Statistical methods (Cpk, DOE)

Documentation (DMR, MPIs)

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Oracle ERP/MES

Minitab

Excel

Job description

The role emphasizes process development, pilot manufacturing oversight, and sustaining activities on the production line while solving complex technical issues in a fast-paced

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