Manufacturing Engineer II – MedTech Process Innovator

Biopharma Asia

Santa Clara (CA)

On-site

USD 73,000 - 117,000

Full time

14 days+

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Benefits offered by this job

Annual performance bonus

Medical, dental, vision insurance

Retirement plan (401(k))

Vacation up to 120 hours per year

Job summary

Johnson & Johnson in Santa Clara, CA is hiring a Manufacturing Engineer II - Shockwave Medical to join our team. This role provides engineering support to Production and develops processes, tooling, and fixtures for commercial products.

You will drive process improvements, participate in NPI transfers, and ensure quality systems compliance. The ideal candidate has a Bachelor's in engineering and 3–5 years in a medical device setting, with experience in Lean Six Sigma and MES/ERP systems.

Qualifications

Bachelor’s degree in engineering.
3–5 years in a medical device environment.
Knowledge of QSRs, FDA, ISO, MDD, MDR requirements.
Understanding of Lean and Six Sigma concepts.
Experience with Validation of Medical Devices (IQ-OQ-PQ).
SolidWorks drawings experience.
Ability to work in a fast-paced environment and manage priorities.
Experience with MES and ERP (Oracle) preferred.

Responsibilities

Actively collaborate with Production to resolve product/process/equipment problems.
Identify and participate in process/product, tooling, equipment, fixtures and cost reduction projects.
Coordinate testing and analysis with stats using Minitab or Excel.
Support new product introductions, including scale-up and transfer to alternate sites.
Develop and maintain MPIs, FMEAs, and DMR documents.
Create, maintain and transfer BOMs and LHRs into Item Structures and definitions.
Support resolution of quality events (NCR, CAPA, audits).
Create and release label files for product labels.
Execute process validation protocols and reports.