Senior Design Quality Engineer, NPD

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

401(k) program

Pension plan

Paid time off 120 hours/year

Job summary

Johnson & Johnson in Santa Clara, CA seeks a Senior Design Quality Engineer for New Product Development to lead quality engineering in early-stage products. This role drives product quality strategy across development from concept to steady-state.

Responsibilities include defining verification/validation, ensuring GMP/ISO compliance, and collaborating with partners. A Bachelor’s in Engineering and 5+ years in quality, with GD&T and medical device experience, are required; travel up to 25% may be

Qualifications

• Bachelor’s degree in Engineering or related science from an accredited program.
• At least 5 years of quality experience in medical devices or regulated field.
• New product development experience.
• GD&T knowledge; applied statistics and quality engineering methods.

Responsibilities

• Launch and stabilize new product launches through concept, design, development, and steady-state processes.
• Define verification and validation strategies and product requirements.
• Ensure GMP/ISO compliance and drive defect prevention.
• Engage partners to drive consensus and resolve issues.
• Provide statistical support and analytical problem solving for product development and manufacturing.
• Review design control, manufacturing, quality, engineering and validation documents for conformance.

Skills

Statistical methods

Quality engineering

GD&T knowledge

Problem solving

Teamwork

Design control knowledge

Education

Bachelor's Degree in Engineering or related science

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 Required

• 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 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 engaging in a team-based environment
• Ability to travel up to 25%
• Moderate domestic and international

Preferred

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.

Required Skills:

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 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

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 https://www.jnj.com/.