Manager, R&D Shockwave Medical New Brighton, Minnesota

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats pioneering the development and commercialization of the innovative ShockwaveReducerSystem. We are creating new opportunities for patients and physicians in the treatment of refractory angina long-lasting debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. We are working with the cardiology community to bring these patients relief from their symptoms and hopefully improve their quality of life.

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 companys 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 companys 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 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 :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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: - Experience:

Manager