Manager, NPI Engineering - Circulatory Restoration

Hardware FYI; Santa Clara (CA); On-site; USD 121,000 - 209,000; Full time

Benefits offered by this job

Annual performance bonus

Job summary

Johnson & Johnson, a global leader in health care, is seeking a Manager, NPI Engineering – Circulatory Restoration in Santa Clara. This role leads product and process development, mentoring engineers, and ensuring strict design control and regulatory compliance.

You will guide cross-functional teams through concept, clinical trials, and commercial release, focusing on cardiovascular catheter products. A rigorous, fast-paced environment requires strong leadership and communication skills.

Qualifications

• B.S. in Engineering or equivalent work experience.
• Minimum of 10 years’ progressive experience in medical device development.
• 3+ years’ experience leading projects through all development phases.
• 2+ years managing direct reports or equivalent experience.
• Knowledge of QSR and applicable Quality System Standards.
• Experience with disposable medical device development, preferably coronary/vascular catheters.
• Strong understanding of engineering materials, design for safety and manufacturability.
• Excellent communication and presentation skills; able to lead a team.

Responsibilities

• Lead cross-functional project activities from concept through clinical trial and commercial release.
• Mentor and support development and engineering activities, focusing on catheter design and development.
• Design and develop products and processes in compliance with Design Control and regulatory requirements.
• Coordinate technical personnel and activities for new and improved products and processes.
• Ensure documentation, lab notebooks, and design history files are complete and compliant.
• Manage outside vendors and contractors providing products or services.
• Communicate project timelines and milestones to teams and management.
• Provide regular updates on milestones and issues to project teams.

Skills

Agile decision making

Leadership

Project management

Team management

Design control

Quality systems

Communication

Problem solving

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 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: Supply Chain Engineering

Job Sub

Function: Process Engineering

Job Category: People Leader

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

Job Description: Johnson & Johnson is hiring for a

Manager, NPI Engineering – Circulatory Restoration

Santa Clara, CA.

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Position Overview

The Manager, NPI Engineering 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 products and processes 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, Engineering Reports 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 product development, as defined by product specification, process development, and manufacturing technologies.
• Approve test methods, acceptance criteria, and test equipment for all stages of product development.
• 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 and processes are compatible with other products and processes in the intended operating system, and have met all requirements per design control process.
• Other duties as assigned.
• Provide technical leadership for projects, including managing process and technology development teams.
• Maintain up-to-date knowledge of competitive technologies and biomedical developments relevant to the company's products.
• Ensures that products and processes satisfy acceptable quality standards and customer needs with consensus from cross-functional groups.
• Support company goals, policies, procedures, quality systems, and compliance with FDA and other regulatory bodies.

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

NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Additional Information

• 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)).
• 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. https://www.careers.jnj.com/employee-benefits

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: Agile Decision Making, Benchmarking, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Team Management, Technical Research, Technical Support

The anticipated base pay range for this Bay Area position is:$121,000.00 - $209,300.00

Additional Description for Pay Transparency

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