NPI Manufacturing Manager

Company: Exokeryx, Inc.
Location: Santa Clara
Posted on: March 25, 2025

Job Description:

NPI Manufacturing Manager page is loadedNPI Manufacturing ManagerApply remote type Fully Onsite locations Santa Clara, California, United States of America time type Full time posted on Posted 3 Days Ago job requisition id R-004694At 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 Job Function: Supply Chain ManufacturingJob Sub Function: Manufacturing AssemblyJob Category: People LeaderAll Job Posting Locations: Santa Clara, California, United States of AmericaJob Description:Johnson & Johnson is hiring for a NPI Manufacturing Manager 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 OverviewThe NPI (New Product Introduction) Manufacturing Manager oversees manufacturing operations from Phase 4 (Process Validation) through to Commercialization, including both Limited and Full Market Release. This role is accountable for key Tier 2 metrics, such as daily output, daily yield, absenteeism, non-conformances, and safety, while ensuring adherence to the Production Plan Schedule. The NPI Manufacturing Manager is responsible for driving process improvement, executing the Operations Strategy, and serving as the primary Subject Matter Expert in production activities.This position will manage the Production Supervisors for both 1st and 2nd shifts, as well as the Lead Trainer in the Training Innovation Center. The NPI Manufacturing Manager will work closely with Engineering to optimize manufacturing processes and evaluate and enhance training programs related to those processes. The NPI Manufacturing Manager will also collaborate across departments, including R&D, Quality, Supply Chain, Facilities and EH&S. Additionally, the role plays a key part in cultivating a culture of excellence as the company strives to become a Technology Center of Excellence in facilitating New Product Introduction into the production environment.Essential Job Functions

• Ensure production demands are met while adhering to all regulations and procedures.
• Oversee the maintenance of the clean room, ensuring a safe and organized work environment that promotes employee health and compliance.
• Manage production resources to meet or exceed output goals, including creating schedules, timelines, and identifying necessary resources, while quickly addressing issues that may impact schedule, product quality and production efficiency.
• Collaborate with cross-functional departments, such as R&D, Quality Control, Materials Management, Facilities, Manufacturing Engineering, and EH&S, to coordinate manufacturing activities.
• Continuously evaluate production operations to identify opportunities for process improvements and enhanced efficiency.
• Ensure all manufacturing activities comply with approved company procedures and standards.
• Address any issues raised during site reviews and provide appropriate documentation for any missed targets. Responsible for tracking and coordinating non-conformances related to production.
• Conduct or coordinate various training sessions for production personnel, focusing on standard operating procedures, work instructions, safety protocols and quality compliance.
• Represent the Production team in Operational Strategy Initiatives, including Digital Transformation and Operational Excellence projects.
• Perform other duties as assigned. This list is not exhaustive and may include additional responsibilities, duties, and skills as required.Requirements
  • Bachelor's degree in Engineering or related discipline, or equivalent experience.
  • Minimum of ten (10) years of experience in Production/Manufacturing within a medical device environment, with at least five (5) years in a management or supervisory role.
  • Previous experience working in CER preferred.
  • Proven ability to manage resources, including time, budget and personnel. Strong people management skills are essential.
  • In-depth knowledge of and compliance with relevant Quality System requirements, such as QSRs, FDA, ISO, MDD and other applicable industry standards and regulations.
  • Excellent written and verbal communication skills, with the ability to communicate effectively across all levels of the organization.
  • Strong presentation skills, capable of delivering presentations to diverse audiences.
  • Ability to thrive in a fast-paced environment while managing multiple priorities.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 anticipated base pay for this position is $114,000-$197,800 annually.
    • 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. 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.The anticipated base pay range for this position is:Additional Description for Pay Transparency:About UsAt 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 .
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