Manager, R&D - Shockwave Medical - New Brighton, Minnesota

Johnson & Johnson Co.; New Brighton (MN); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Retirement plan (401(k))

Paid time off benefits

Parental leave

Job summary

Johnson & Johnson is hiring a Manager, R&D - Shockwave Medical to join our New Brighton, Minnesota team. You will lead product and process development, mentor engineers, and manage cross-functional projects from concept through clinical trials to commercial release.

The role emphasizes design control, regulatory compliance (FDA/ISO), and collaboration across engineering, manufacturing, and QA to deliver safer, more effective cardiovascular therapies.

Qualifications

• B.S. in Engineering or equivalent work experience.
• 10+ years progressive experience in medical device development, including 3+ years leading projects.
• 2+ years managing direct reports.
• Knowledge of QSR and applicable Quality System Standards.
• Experience with disposable medical device development preferably coronary and/or vascular catheters.
• Strong understanding of materials, design for safety, reliability and manufacturability.
• Solid communication and presentation skills; capable of leading a team.
• Experience taking a product from concept through clinical or commercial release.
• Ability to work in a fast-paced environment with multiple priorities.
• Team or independent work with flexibility to changing requirements.
• Lift up to 25lbs as needed.

Responsibilities

• Lead and mentor engineers/technicians.
• Manage cross-functional project from concept to commercial release.
• Mentor development and engineering activities, focusing on catheter design and development.
• Design and develop products in compliance with Design Controls, FDA/ISO/MDD requirements.
• Coordinate technical personnel across development and manufacturing.
• Document development activities with lab notebooks and history files.
• Coordinate cross-functional alignment and support for program success.
• Manage outside vendors and contractors.

Skills

Engineering leadership

Project management

Medical device development

Design control

Regulatory compliance

Cross-functional collaboration

Communication skills

Education

B.S. in Engineering or equivalent

Job description

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Product Development

Job Sub Function: Biomedical Engineering

Job Category: People Leader

All Job Posting Locations: New Brighton, Minnesota, United States of America

Job Description: Johnson & Johnson is hiring for a Manager, R&D - Shockwave Medical to join our team located in New Brighton, Minnesota.

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Manager of R&D provides leadership, technical support, and effectively manages and develops direct reports. Responsible for product and process development, resources, and project management activities associated with executing the company's goals and objectives

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.
• Ensures 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

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.

Required Skills:

Preferred Skills: Advanced Analytics, Bioinformatics, Biological Engineering, Biostatistics, Business Requirements Analysis, Developing Others, Financial Competence, Global Market, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Product Development, Research and Development, Researching, Resource Planning, SAP Product Lifecycle Management, Team Management

The anticipated base pay range for this position is : $117,000.00 - $201,250.00

Additional Description for Pay Transparency:

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 Colorado -48 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
• Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year

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