Sr. NPI Engineer - Johnson and Johnson MedTech, Circulatory Restoration

Johnson & Johnson Co.; Santa Clara (CA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

401(k) plan

Pension

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson is hiring a Sr. NPI Engineer for our Santa Clara, CA team.

The role collaborates with R&D, Quality, Regulatory and Production to design, test and implement manufacturing processes, tooling and fixtures, while addressing non-conformances and analyzing process data for both new and existing products. The position requires mechanical/biomedical engineering credentials with 5+ years experience (3 years with Master’s) in the medical device field, plus knowledge of QSR/FDA/ISO/MDR,

Qualifications

• Engineering experience in the medical device industry preferred.
• Knowledge of Quality System requirements (QSRs, FDA, ISO, MDR).
• Understanding of Lean and Six Sigma principles.
• Experience with IQ-OQ-PQ validation.

Responsibilities

• Collaborate with R&D, Quality, Regulatory and Production to design, develop, test and implement manufacturing processes, tooling and fixtures.
• Support Quality in addressing non-conformances.
• Collect and analyze process performance data and capabilities for new and existing products.
• Identify process requirements and design equipment/fixtures for process development and manufacturing.
• Develop and maintain design/control documentation in line with FDA/ISO/MDR and quality systems.
• Prototype and develop designs, processes and test methods to support new product development and scale-up for commercialization.
• Create and execute process verification and validation protocols and reports.
• Represent Operations as the primary contact for manufacturing-related project activities and pilot manufacturing.
• Stay current with competitive technologies in medical/biomedical fields related to the company’s products.
• Lead or participate in product and process engineering problem-solving using DMAIC or similar methods.
• Drive continuous improvement projects with development engineers and technicians.
• Apply Lean principles to reduce waste and improve productivity.

Skills

Lean Six Sigma

Analytical thinking

Cross-functional collaboration

Prototyping

Education

Bachelor's in Mechanical or Biomedical Engineering

Master's in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP/MES Oracle

Job description

Job Function

• Job Function: R&D Product Development
• Job Sub Function: Biomedical Engineering
• Job Category: Scientific/Technology
• All Job Posting Locations: Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring for a Sr. NPI Engineer to join our team located in Santa Clara, CA.

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

Cardiovascular Solutions from Johnson & Johnson Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary and peripheral artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information on circulatory restoration, visit our website.

Position Overview

• Collaborate with R&D, Quality, Regulatory, and Production teams to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
• Support Quality in addressing and resolving non-conformances.
• Collect and analyze process performance data and capabilities for both new and existing products.
• Identify process requirements and support operations by designing, developing, and implementing equipment and fixtures for process development and manufacturing.
• Develop and maintain documentation in compliance with design control, product configuration, manufacturing procedures, and lot history records (e.g., Bills of Materials, MPIs, LHRs), in alignment with FDA, ISO, MDR, and other applicable Quality System requirements
• Prototype and develop designs, processes, and test methods to support new product development and scale-up for commercialization.
• Create and execute process verification and validation protocols and reports.
• Represent Operations as the primary point of contact for manufacturing-related project activities, including responding to internal and external requests and supporting pilot manufacturing.
• Stay current with competitive technologies and advancements in medical, technical, and biomedical fields related to the company’s products.
• Lead or participate in product and process engineering problem-solving using DMAIC or similar methodologies.
• Drive or support continuous improvement projects for processes and products, working closely with development engineers and technicians.
• Apply Lean manufacturing principles to reduce waste and improve productivity in production processes.
• Support Procurement and R&D with supplier selection and process development.
• Conduct productivity and cost analyses, including calculating direct labor and material costs for new and existing products, and identifying cost reduction opportunities.
• Perform other duties as assigned.

This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required.

Requirements

• Bachelor’s degree in Mechanical or Biomedical Engineering with 5+ years’ of engineering experience, or a Master’s degree in Mechanical or Biomedical Engineering with 3 years’ of engineering experience (preferred).
• Engineering experience in the medical device industry is highly preferred.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other relevant regulations.
• Understanding of Lean and Six Sigma principles.
• Experience with medical device validation (IQ-OQ-PQ).
• Basic understanding of statistical methods (e.g., Cpk, Hypothesis Testing, DOE’s, Gage R&R) a plus.
• Proficiency in SolidWorks for creating and maintaining drawings.
• Experience with ERP and MES (Oracle preferred).
• Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
• Experience in early-stage catheter based cardiovascular devices project is a strong plus.
• Effective communication skills across all levels of the organization.
• Proficiency in Microsoft Office software (Excel, Word, PowerPoint).
• Ability to work in a fast-paced environment while managing multiple priorities.
• Ability to work both independently and collaboratively, with flexibility to adapt to changing requirements.
• Must be able to sit for prolonged periods (more than 2 consecutive hours in an 8-hour day).
• Must be able to lift objects weighing up to 25lbs or more.

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 & Preferred Skills

• Analytical Reasoning
• Bioinformatics
• Biological Engineering
• Biological Sciences
• Biostatistics
• Coaching
• Data Savvy
• Detail-Oriented
• Feasibility Studies
• Inventory Management
• Preclinical Research
• Project Schedule
• Prototyping
• Research and Development
• Researching
• SAP Product Lifecycle Management
• Technologically Savvy

The anticipated base pay range for this Bay Area position is: $109,000.00 - $174,800.00

Additional 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 period10 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

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive.

Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.