Johnson & Johnson MedTech
Manager, R&D - Shockwave Medical
Johnson & Johnson MedTech, Santa Clara, California, us, 95053
Join to apply for the
Manager, R&D - Shockwave Medical
role at
Johnson & Johnson MedTech All Job Posting Locations: Santa Clara, California, United States of America Position Overview
Johnson & Johnson is hiring for a Manager, R&D– Shockwave Medical to join our team located in Santa Clara, CA. 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/. Essential Job Functions
Manage, lead, and mentor engineer(s) and/or technician(s). Lead all cross‑functional project activities from concept through clinical trial and commercial release of product. Mentor and support a variety of development and engineering activities, which mainly focus on catheter design and development. Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO, and MDD requirements. Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes. Ensure that development activities are properly documented through lab notebook, history file, and other records. Coordinate cross‑functional alignment and support for program success. Manage outside vendors and contractors providing products or services. Create, maintain, and communicate project timelines for internal and outside development projects. Provide regular updates of key milestones and issues to the project team as well as management. Identify issues and recommend solutions for products in development. Contribute ideas to new products, as defined by product specification requirements. Approve test methods, acceptance criteria, and test equipment for all stages of product development. Coordinate and participate in events, which provide clinical feedback such as animal studies, physician interface meetings, and Human Clinical Studies. Ensure that products satisfy acceptable quality standards and customer needs with consensus from cross‑functional groups. Review and approve documents as specified in Document Control SOP. Compile the Design History File and conduct design reviews in compliance with Design control procedures. Ensure that products have capable manufacturing processes and that process verifications and validations are completed. Interact with cross‑functional groups to ensure that products are compatible with other products in the intended operating system, and have met all requirements per design control process. Other duties as assigned. Requirements
B.S. in Engineering or equivalent work experience. Minimum of 10 years’ progressive experience in medical device development, including 3+ years’ experience in leading projects in all phases of product development. 2+ years managing direct reports or equivalent experience. Knowledge of QSR and applicable Quality System Standards. Experience with disposable medical device development preferably coronary and/or vascular catheters. Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability. Solid communication and presentation skills with level of comfort being the spokesperson and leader of a team. Experience taking a product from concept through clinical or commercial release. Ability to work in a fast‑paced environment while managing multiple priorities. Operate as a team and/or independently while demonstrating flexibility to changing requirements. Employee may be required to lift objects up to 25lbs. Equal Opportunity Employer
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Pay Transparency
The anticipated base pay range for this position is $141,000 - $227,000. Benefits
Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time‑off benefits: Vacation –120 hours per calendar year; Sick time –40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year; Holiday pay, including Floating Holidays –13 days per calendar year; Work, Personal and Family Time – up to 40 hours per calendar year; Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child; Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member; Caregiver Leave – 10 days; Volunteer Leave – 4 days; Military Spouse Time‑Off – 80 hours. Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
#J-18808-Ljbffr
Manager, R&D - Shockwave Medical
role at
Johnson & Johnson MedTech All Job Posting Locations: Santa Clara, California, United States of America Position Overview
Johnson & Johnson is hiring for a Manager, R&D– Shockwave Medical to join our team located in Santa Clara, CA. 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/. Essential Job Functions
Manage, lead, and mentor engineer(s) and/or technician(s). Lead all cross‑functional project activities from concept through clinical trial and commercial release of product. Mentor and support a variety of development and engineering activities, which mainly focus on catheter design and development. Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO, and MDD requirements. Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes. Ensure that development activities are properly documented through lab notebook, history file, and other records. Coordinate cross‑functional alignment and support for program success. Manage outside vendors and contractors providing products or services. Create, maintain, and communicate project timelines for internal and outside development projects. Provide regular updates of key milestones and issues to the project team as well as management. Identify issues and recommend solutions for products in development. Contribute ideas to new products, as defined by product specification requirements. Approve test methods, acceptance criteria, and test equipment for all stages of product development. Coordinate and participate in events, which provide clinical feedback such as animal studies, physician interface meetings, and Human Clinical Studies. Ensure that products satisfy acceptable quality standards and customer needs with consensus from cross‑functional groups. Review and approve documents as specified in Document Control SOP. Compile the Design History File and conduct design reviews in compliance with Design control procedures. Ensure that products have capable manufacturing processes and that process verifications and validations are completed. Interact with cross‑functional groups to ensure that products are compatible with other products in the intended operating system, and have met all requirements per design control process. Other duties as assigned. Requirements
B.S. in Engineering or equivalent work experience. Minimum of 10 years’ progressive experience in medical device development, including 3+ years’ experience in leading projects in all phases of product development. 2+ years managing direct reports or equivalent experience. Knowledge of QSR and applicable Quality System Standards. Experience with disposable medical device development preferably coronary and/or vascular catheters. Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability. Solid communication and presentation skills with level of comfort being the spokesperson and leader of a team. Experience taking a product from concept through clinical or commercial release. Ability to work in a fast‑paced environment while managing multiple priorities. Operate as a team and/or independently while demonstrating flexibility to changing requirements. Employee may be required to lift objects up to 25lbs. Equal Opportunity Employer
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Pay Transparency
The anticipated base pay range for this position is $141,000 - $227,000. Benefits
Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time‑off benefits: Vacation –120 hours per calendar year; Sick time –40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year; Holiday pay, including Floating Holidays –13 days per calendar year; Work, Personal and Family Time – up to 40 hours per calendar year; Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child; Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member; Caregiver Leave – 10 days; Volunteer Leave – 4 days; Military Spouse Time‑Off – 80 hours. Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
#J-18808-Ljbffr