Sr Mgr R&D Electrical Eng, Systems - Shockwave

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 ;br>
Job Function:
R&D Product Development

Job Sub Function:
Biomedical Engineering

Job Category:
People Leader

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr Manager of R&D Electrical Engineering Systems - Shockwave to join our team located in Santa Clara, CA.

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 Sr. Manager of R&D Electrical Engineering Systems provides leadership in the development and sustaining of innovative products to treat vascular diseases, 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, consistent with Shockwave Medical's strategic plan.

Essential Job Functions

• Manage, lead, and mentor engineer(s); may include multiple level reporting structure (mechanical and electrical engineering).
• Lead cross-functional project activities of product and fixture testing and development.
• Mentor and support a variety of development and engineering activities, which mainly focus on capital equipment design and development (primarily pulse generators).
• Provide guidance to other managers cross-functionally and within R&D.
• Design and develop product(s) and fixtures in full compliance with the company's Design Control requirements and consistent with FDA, ISO, MDD, MDR and other applicable regulations/requirements.
• Coordinate technical personnel and their activities involved in testing and developing new and improved products, fixtures, and manufacturing processes.
• Ensure that development activities are properly documented through lab notebook, PLM requirements, design 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 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.
• Proactively identify and resolve challenges which could significantly delay project timelines.
• Work under high level of autonomy.
• Provide leadership, goal setting, communication and facilitation skills as needed to guide and motivate project personnel.
• Contribute ideas to new designs, 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.
• Seen as go-to expert for specific area/topic(s) within Systems Engineering and R&D.
• Altium and SolidWorks proficiency preferred.
• Other duties as assigned.

Requirements

• B.S. in Electrical, Mechanical or Biomedical Engineering with 12+ years of experience, or M.S. with 10+ years of experience in medical device development.
• Minimum of 5 years' experience of direct reports technical management.
• Knowledge of IEC 60601-1, 21 CFR820 and applicable Quality System Standards.
• Experience with capital equipment medical device development, preferably pulse generator/RF generator based.
• Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability.
• Solid communication and presentation skills as the spokesperson and leader of a team.
• Experience taking ownership of multiple initiatives throughout the business, from development to sustaining work
• Ability to work in a fast-paced environment while managing multiple priorities.
• Ability to operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to lift objects up to 25 lbs.

Additional Information:

The anticipated salary range for this position is

Bay Area: $168,000-$271,400

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 year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. ;/li>

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
Bay Area: $168,000-$271,400

Additional Description for Pay Transparency: