Johnson Johnson is recruiting for Senior Quality Engineer for Shockwave Medical Inc. located in Santa Clara, California.

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson Johnson, we all belong.

Position Overview:
The Sr. Quality Engineer will support manufacturing and work cross-functionally toresolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports.

Essential Job Functions:

Responsible for developing, applying, revising and maintaining quality standards for processingmaterials/products into partially or finished products.Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.Prepares documentation for inspection/testing procedures, development studies, validationprotocols and reports, quality plans, and product defect investigations. Must be able to write atechnical document with sufficient clarity, detail and correctness to be submitted for regulatoryreview with confidence. Must be able to review and provide value-added feedback to otherswriting such documents.Fully competent engineer in all conventional aspects of the subject matter, functional area, andassignments.Provides guidance to manufacturing and development engineers regarding documentation,process controls, data feedback systems, and best quality practices.Independently performs most assignments with an understanding of the overall expectations.Receives technical guidance on unusual or complex problems and supervisory approval onproposed plans for projects.Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a majorproject.Performs work which involves conventional engineering practice but may include a variety ofcomplex features such as conflicting design requirements, unsuitability of conventional materials,and difficult coordination requirements.Work requires a broad knowledge of precedents in the specialty area and a good knowledge ofprinciples and practices of related specialties. Familiarity with FDA guidance documents and ISOand ASTM standards related to quality and medical device industry is an asset.Independently assesses if components, sub-assemblies, products meet specification and caninitiate, investigate and resolve non-conformances by working in conjunction with a multidisciplinaryteam.Responsible for ensuring personal and company compliance with all Federal, State, local andcompany regulations, policies and procedures for Health, Safety and Environmental compliance.May participate in design reviews and pre-validation assessments to ensure the safe andenvironmentally sound start-up of new processes, and ensure the process has adequate andappropriate process controls. May be responsible for participating and/or taking lead role indeveloping the risk management plan for new projects transitioning into manufacturing. (Hazardassessment, design trace matrix development, DVV testing, and FMEA).May technically supervise or coordinate the work of engineers, technicians, and others who assistin specific assignments.May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would bean asset. Familiarity with IEC 60601 and IEC 62304 is an asset.Processing, investigating, and completing customer complaints, which could require direct emailresponses to customers.Composes technical complaint reports timely and accurately based on reported information anddevice investigation data.Responsible for developing and maintaining calibration requirements for tools and equipment inthe RD, Manufacturing, and Quality areas.Knowledge of statistics and Minitab, including process capability and data normality assessments,analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance intervalassessments for variable and attribute data, design of experiment (DOE), and variable and attributesampling plan applications would be a great asset.Other duties as assigned.

Johnson Johnson is recruiting for Senior Quality Engineer for Shockwave Medical Inc. located in Santa Clara, California.

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson Johnson, we all belong.

Position Overview:
The Sr. Quality Engineer will support manufacturing and work cross-functionally toresolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports.

Essential Job Functions:

Responsible for developing, applying, revising and maintaining quality standards for processingmaterials/products into partially or finished products.Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.Prepares documentation for inspection/testing procedures, development studies, validationprotocols and reports, quality plans, and product defect investigations. Must be able to write atechnical document with sufficient clarity, detail and correctness to be submitted for regulatoryreview with confidence. Must be able to review and provide value-added feedback to otherswriting such documents.Fully competent engineer in all conventional aspects of the subject matter, functional area, andassignments.Provides guidance to manufacturing and development engineers regarding documentation,process controls, data feedback systems, and best quality practices.Independently performs most assignments with an understanding of the overall expectations.Receives technical guidance on unusual or complex problems and supervisory approval onproposed plans for projects.Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a majorproject.Performs work which involves conventional engineering practice but may include a variety ofcomplex features such as conflicting design requirements, unsuitability of conventional materials,and difficult coordination requirements.Work requires a broad knowledge of precedents in the specialty area and a good knowledge ofprinciples and practices of related specialties. Familiarity with FDA guidance documents and ISOand ASTM standards related to quality and medical device industry is an asset.Independently assesses if components, sub-assemblies, products meet specification and caninitiate, investigate and resolve non-conformances by working in conjunction with a multidisciplinaryteam.Responsible for ensuring personal and company compliance with all Federal, State, local andcompany regulations, policies and procedures for Health, Safety and Environmental compliance.May participate in design reviews and pre-validation assessments to ensure the safe andenvironmentally sound start-up of new processes, and ensure the process has adequate andappropriate process controls. May be responsible for participating and/or taking lead role indeveloping the risk management plan for new projects transitioning into manufacturing. (Hazardassessment, design trace matrix development, DVV testing, and FMEA).May technically supervise or coordinate the work of engineers, technicians, and others who assistin specific assignments.May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would bean asset. Familiarity with IEC 60601 and IEC 62304 is an asset.Processing, investigating, and completing customer complaints, which could require direct emailresponses to customers.Composes technical complaint reports timely and accurately based on reported information anddevice investigation data.Responsible for developing and maintaining calibration requirements for tools and equipment inthe RD, Manufacturing, and Quality areas.Knowledge of statistics and Minitab, including process capability and data normality assessments,analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance intervalassessments for variable and attribute data, design of experiment (DOE), and variable and attributesampling plan applications would be a great asset.Other duties as assigned.

Requirements:

BS in a related engineering discipline and 5 years of related experience; or MS in a relatedengineering discipline and 3 years of related experienceExperience in the medical device industry is highly preferredStrong technical writing skills are requiredExperience in customer complaint investigations and complaint report writingExperience in manufacturing support as a Quality EngineerMust be proactive, self-motivated, and work independently with minimal supervisionExperience with balloon catheters and electrical systems is strongly preferredExperience in completing Medical Device Reports (MDR) and Vigilance (MDV) submissions is an assetExperience in writing and reviewing design verification and validation protocolsPreferred experience in generating documentation and criteria for validation of manufacturing linetransfer to alternative sitesCertified Quality Engineer would be an assetMust be willing to travel up to 10% of the timeEffective communication skills with all levels of management and organizationsOperate independently and adaptability to changing requirementsAbility to work in a fast-paced environment, managing multiple priorities

The anticipated base pay range for this position is 105.040 to 142,600 USD.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Employees are eligible for the following time off benefits:Vacation – up to 120 hours per calendar yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on January 7, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Requirements:

BS in a related engineering discipline and 5 years of related experience; or MS in a relatedengineering discipline and 3 years of related experienceExperience in the medical device industry is highly preferredStrong technical writing skills are requiredExperience in customer complaint investigations and complaint report writingExperience in manufacturing support as a Quality EngineerMust be proactive, self-motivated, and work independently with minimal supervisionExperience with balloon catheters and electrical systems is strongly preferredExperience in completing Medical Device Reports (MDR) and Vigilance (MDV) submissions is an assetExperience in writing and reviewing design verification and validation protocolsPreferred experience in generating documentation and criteria for validation of manufacturing linetransfer to alternative sitesCertified Quality Engineer would be an assetMust be willing to travel up to 10% of the timeEffective communication skills with all levels of management and organizationsOperate independently and adaptability to changing requirementsAbility to work in a fast-paced environment, managing multiple priorities

The anticipated base pay range for this position is 105.040 to 142,600 USD.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Employees are eligible for the following time off benefits:Vacation – up to 120 hours per calendar yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on January 7, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.