Staff Manufacturing Engineer (NPI) - Shockwave at Johnson & Johnson

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Medical Devices, HealthcareIndustries

Requirements

Expertise in designing, developing, testing, documenting, and implementing manufacturing processes, tooling, and fixtures throughout the product lifecycle
Ability to collaborate closely with R&D Process Engineer (Subject Matter Expert), Production, Quality, and R&D teams
Knowledge of company’s Design Control and applicable regulatory requirements
Proficiency in data collection and analysis for process performance and capabilities
Experience in prototyping, proof-of-concept designs, and bench models in simulated environments
Skills in developing, validating, and maintaining test methods
Capability to perform tolerance analysis for components, materials, packaging, and supplies
Expertise in leading development and maintenance of process Failure Modes and Effects Analyses (pFMEAs)
Ability to prepare user requirements, technical specifications, and design specifications
Experience in identifying process needs, supporting operations management, and implementing equipment/fixturing
Proficiency in developing and maintaining documentation (e.g., bills of materials, MPIs, LHRs) for design control and Quality System requirements
Skills in evaluating and improving engineering processes
Knowledge of DMAIC methodology for problem-solving
Experience leading or supporting process and product improvement projects
Ability to assist Procurement and R&D with supplier selection and technical development
Capability to recommend and evaluate new technologies for system performance and reliability
Proficiency in conducting productivity and cost analyses, including direct labor, time studies, and materials cost estimates
Experience creating stability matrices for product transfer sustainability

Responsibilities

Collaborate with R&D, QA, and Production to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures
Design and develop manufacturing processes in compliance with Design Control and regulatory requirements
Collect and analyze data on process performance and capabilities for new and existing products
Prototype and develop proof-of-concept designs and bench models to test concepts
Develop, validate, and maintain test methods
Perform tolerance analysis for components, materials, packaging, and supplies
Lead development and maintenance of process FMEAs (pFMEAs)
Prepare user requirements, technical specifications, and design specifications
Identify process needs, support operations management, and implement equipment and fixturing
Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, etc
Evaluate existing engineering processes and implement improvements
Lead or participate in product/process problem-solving using DMAIC methodology
Lead or support process and product improvement projects with production, R&D engineers, and technicians
Assist Procurement and R&D with supplier selection and technical development
Recommend and evaluate new technologies to improve performance and reliability
Conduct productivity and cost analyses, including labor, time studies, and materials estimates, to improve efficiency and scalability
Create stability matrix in Phase 4 to assess product transfer sustainability

Skills

Key technologies and capabilities for this role

Manufacturing EngineeringNPIProcess DevelopmentTooling DesignFixture DesignProduct Lifecycle ManagementR&D CollaborationProduction SupportQuality AssuranceMedical Device ManufacturingIntravascular LithotripsyIVL

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The position is located in Santa Clara, CA, indicating it requires on-site work at the specified location.

What is the salary range for this Staff Manufacturing Engineer role?

This information is not specified in the job description.

What are the key responsibilities of the Staff Manufacturing Engineer?

The role involves designing, developing, testing, documenting, and implementing manufacturing processes, tooling, and fixtures, while collaborating with R&D, QA, and Production teams.

What teams will I collaborate with in this role?

You will work closely with R&D, QA, Production, and specifically the R&D Process Engineer.

What makes a strong candidate for this position?

A strong candidate has experience in manufacturing process development for medical devices, compliance with design controls and regulations, data analysis, prototyping, and leading pFMEAs.

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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