Manufacturing Engineer II - Shockwave at Johnson & Johnson

Santa Clara, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Medical DevicesIndustries

Requirements

Bachelor’s degree in engineering
3-5 years of experience in a medical device environment
Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations
Understanding of Lean

Responsibilities

Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems
Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects
Coordinate and/or perform functional and destructive testing to support Engineering Reports. Document the results and provide a statistical analysis using Minitab or Excel
Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites
Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents
Create, maintain and transfer paper Bill of Materials (BOM’s) and Lot History Records (LHR’s) into Item Structures, Work Definitions and electronic LHR’s
Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements
Create and release label files used for printing product labels
Create and execute process validation protocols and reports
Other duties as assigned

Skills

Key technologies and capabilities for this role

Manufacturing EngineeringSupply Chain EngineeringMedical DevicesIntravascular LithotripsyIVLProcess Innovation

Questions & Answers

Common questions about this position

What is the salary for the Manufacturing Engineer II position?

This information is not specified in the job description.

Is this Manufacturing Engineer II role remote or on-site?

The position is located in Santa Clara, California, United States of America, indicating it is an on-site role.

What are the key responsibilities of the Manufacturing Engineer II?

The role involves providing engineering support to Production, designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product, and sustaining activities on the production line such as raw material, process, and equipment issues.

What is the company culture like at Johnson & Johnson for this role?

Johnson & Johnson emphasizes healthcare innovation to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized solutions, fueled by innovation at the intersection of biology and technology in their Shockwave Medical portfolio.

What makes a strong candidate for the Manufacturing Engineer II role?

Strong candidates should have experience providing sustaining support to production, identifying process improvements, performing functional and destructive testing with statistical analysis using Minitab or Excel, and participating in new product introductions including scaling and transfer.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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