Sr Manufacturing Mechanical Engineer - Shockwave at Johnson & Johnson

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

Expertise in project planning, timeline development & management, and maintaining project schedules
Ability to act as primary technical point of contact with contract manufacturers and external partners
Experience supporting development transfer activities from R&D & Operations to contract manufacturers/suppliers
Capability to work with local and international suppliers/manufacturing sites for capacity/capability models and make vs. buy assessments
Proficiency in preparation and execution of validation protocols and completion of validation reports
Knowledge in developing and maintaining process risk documentation (e.g., PFMEA) to identify risks and implement preventive/corrective actions
Skills in preparing engineering change orders and coordinating implementation, including training production staff
Experience implementing and managing process improvement and cost reduction projects
Ability to ensure capacity aligns with manufacturing plans
Expertise in lean manufacturing tools (e.g., factory layouts, visual management, 6S, JIT, Kanban) for improving material/information flow
Ability to implement robust, cost-effective manufacturing processes

Responsibilities

Provide technical support to contract manufacturers and component suppliers on implementation and validation of manufacturing lines for Shockwave products
Evaluate and build prototypes, pilot, and production equipment or tooling as appropriate
Troubleshoot and implement changes to improve manufacturing quality and product performance
Assist in identification and pursuit of value improvement and cost improvement projects aligned with business goals
Transfer and scale Shockwave manufacturing processes with contract manufacturers and external partners
Generate capacity/capability models and make vs. buy assessments for site planning
Prepare and execute validation protocols and complete validation reports
Develop and maintain process risk documentation (e.g., PFMEA) and implement preventive/corrective actions

Skills

Key technologies and capabilities for this role

Manufacturing EngineeringMechanical EngineeringMedical DevicesSupply Chain EngineeringIntravascular Lithotripsy

Questions & Answers

Common questions about this position

What is the salary for this Sr Manufacturing Mechanical Engineer position?

This information is not specified in the job description.

Is this role remote or does it require working in an office?

The role is located in Santa Clara, CA, with no mention of remote work options.

What are the key responsibilities for this position?

The role involves technical support to contract manufacturers and suppliers for implementing and validating manufacturing lines, evaluating and building prototypes and production equipment, troubleshooting to improve quality and performance, and pursuing value and cost improvement projects.

What is the work environment like at Johnson & Johnson for this role?

The position is part of a team pioneering Intravascular Lithotripsy (IVL) at Shockwave Medical, focused on innovation at the intersection of biology and technology to develop smarter, less invasive treatments for cardiovascular disease.

What makes a strong candidate for this Senior Manufacturing Engineer role?

Strong candidates will have expertise in manufacturing engineering, experience supporting contract manufacturers and suppliers, and skills in process transfer from R&D to production, scaling manufacturing processes, and driving quality and cost improvements.

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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