Manager, NPI Engineering - Circulatory Restoration

Biopharma Asia; Santa Clara (CA); Presencial; USD 121.000 - 209.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is hiring a Manager, NPI Engineering – Circulatory Restoration for its Santa Clara, CA team. The role leads engineering staff, manages cross-functional projects, and drives product development from concept to commercial release, with a strong emphasis on catheter design and FDA/ISO compliance.

The role requires a BS in Engineering, 10+ years in medical device development, and 2+ years of people leadership.

Formación

• 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.

Responsabilidades

• Lead, mentor, and develop engineers and technicians.
• Oversee cross-functional projects from concept through clinical trial and commercial release.
• Guide catheter design and development activities.
• Ensure Design Control compliance with FDA/ISO/MDD requirements.
• Coordinate resources and timelines for new and improved products and manufacturing processes.
• Maintain design history files and document control records.
• Communicate milestones and issues to project team and management.
• Engage with outside vendors and contractors as needed.

Conocimientos

Process Engineering

Leadership

Project Management

Team Management

Quality Systems

FDA/ISO Compliance

Medical Devices

Educación

B.S. in Engineering

Descripción del empleo

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 to join our team located in 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