Senior Design Quality Engineer, NPD

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year

Holiday pay – 13 days per year

Parental Leave – 480 hours per year

Job summary

Johnson & Johnson MedTech is seeking a Senior Design Quality Engineer for New Product Development in Santa Clara, CA. The role leads quality engineering for NPD, ensuring GMP/ISO compliance and robust design controls.

The ideal candidate has 5+ years in quality, experience with NPD, and strong statistics knowledge. Travel up to 25% may be required for domestic and international coordination.

Qualifications

• Bachelor's Degree in Engineering from an accredited engineering school or related science field.
• 5+ years of quality experience.
• New product development experience.
• GD&T knowledge.
• Experience in medical device industry or other highly regulated field.
• Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity.
• Previous work experience in a team-based environment.

Responsibilities

• Launch and stabilize new product launches through concept, design, development, and steady-state processes.
• Drives development of product requirements, verification strategies, and validation strategies.
• Ensures new product development compliance to GMP, ISO and applicable standards.
• Drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support and analytical problem solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering and validation documents for conformance.
• Develop inspection and sampling plans, test methods, and transfer functions for products and components.
• Support and expertise in developing and executing a reliability strategy during new product development.
• Conducts projects and assignments with technical responsibility.

Skills

New product development experience

GD&T knowledge

Experience in medical device industry

Advanced quality engineering methods

Analytical reasoning

Risk analysis

Education

Bachelor's Degree in Engineering or related science field

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

R&D Product Development

Job Sub Function

R&D Software/Systems Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Santa Clara, California, United States of America

Job Description

The Senior Design Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development.

Responsibilities

• Launch and stabilize new product launches through concept, design, development, and steady-state processes.
• Drives the development of product requirements, verification strategies, and validation strategies.
• Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards
• Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Proactively engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
• Develop inspection and sampling plans, test methods, and transfer functions for products and components.
• Provide support and expertise in developing and executing a reliability strategy during new product development.
• Conducts projects and assignments with technical responsibility.

Basic Qualifications

• Bachelor's Degree in Engineering from an accredited engineering school or related science field
• At least 5 years of quality experience
• New product development experience
• GD&T knowlegde
• Experience in medical device industry or other highly regulated field
• Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity
• Previous work experience engaging in a team-based environment
• Ability to travel up to 25% Moderate domestic and international

Preferred

• Advanced Degree
• Experience with medical electrical-mechanical systems
• Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment.
• ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
• Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
• Prior software quality engineering experience in a product development environment

Preferred Skills:

Analytical Reasoning, Quality Compliance, Quality Control (QC), Quality Planning, Quality Tools, Quality Validation, Risk Analysis

The anticipated base pay range for this position is :

$125,000.00 - $201,250.00

Benefits

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