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

6947-SHOCKWAVE MEDICAL INC. Legal Entity; New Brighton (MN); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson in New Brighton, Minnesota is hiring a Manager, R&D – Shockwave Medical to join our team. The role leads catheter design and development, delivering intravascular lithotripsy solutions for complex cardiovascular disease.

You will mentor engineers and manage cross-functional projects through clinical and commercial release. The position requires a strong background in medical device development, FDA/ISO design controls, and the ability to drive key milestones in a fast-paced

Qualifications

• B.S. in Engineering or equivalent work experience.
• 10+ years in medical device development with leadership.
• 2+ years directing direct reports and project leadership.
• Knowledge of QSR and Quality System Standards.
• Experience with disposable devices; coronary/vascular catheters preferred.
• Strong design for safety, reliability and manufacturability.
• Excellent communication and presentation skills; team leader.
• Experience taking products from concept through release.
• Able to work in a fast-paced environment with multiple priorities.
• Ability to lift up to 25 lbs.

Responsibilities

• Lead, mentor engineers and technicians on project teams.
• Drive cross-functional activities from concept to clinical release.
• Support catheter design and development efforts.
• Ensure design control compliance with FDA/ISO requirements.
• Coordinate resources, vendors and project timelines.
• Document development activities and maintain DHF records.
• Communicate milestones and issues to project teams and management.
• Review test methods, acceptance criteria, and equipment.
• Support clinical studies and external collaborations.

Skills

Leadership

Project management

People management

Quality systems

Medical devices

Catheters

Engineering materials

Communication skills

Product development lifecycle

Teamwork

Physical ability

Education

Engineering degree

Tools

SAP Product Lifecycle Management

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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: 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

Preferred Skills: (none listed)

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 period
• 10 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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.