Design Quality Engineer II

Posted 2 Days Ago
Be an Early Applicant
Warsaw, IN, USA
In-Office
Junior
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Performs design and quality engineering activities for orthopedic medical devices, including risk management, reliability assessment, root cause investigations, corrective action effectiveness, test method development, qualifications, validations, process controls, statistical analysis, and technical reviews. Supports product development, process improvements, quality control plans, technical transfers, and regulatory compliance while collaborating with cross-functional teams.
Summary Generated by Built In

At 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 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:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Warsaw, Indiana, United States of America

Job Description:

Depuy Synthes is the largest, most innovative, and comprehensive orthopaedic business in the world.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
DePuy Synthes is recruiting for two new Design Quality Engineer II team members for our Warsaw, IN location.


Applies basic Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. Participates in and performs tasks on projects and assignments with technical responsibility or strategic input. Receives intermittent, detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.


DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Demonstrates competency to apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.

• Demonstrates competency to apply various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, and effects analysis).

• Contributes to the reliability assessments of product design.

• Contributes to root cause investigations using various problem solving techniques and tools, and assesses effectiveness of corrective actions.

• Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.

• Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.

• Contributes to, implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).

• Participates in technical reviews as appropriate.

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed


EXPERIENCE AND EDUCATION*

• Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field AND 2 or more years related experience.

• Basic knowledge of Quality Engineering/Scientific methods and techniques.

• Basic technical understanding of manufacturing equipment and processes.

• Experience managing tasks or small projects and demonstrating project leadership abilities.

Basic understanding of and application of measuring techniques (for example, mechanical, optical, gages, automation


REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Production and Processing Systems

• Qualification and Validation

• Product Design Support

• Quality Statistics, Data Analysis and Tools

• Product Control and Disposition

• Product Development Support

• Technical Transfer & Scale Up

• Predictive Analytics / Reliability


ADDITIONAL POSITION REQUIREMENTS


• Ability to work in stressful/fast paced environment

• Ability to work and interact with co-workers to accomplish company goals in a team environment

• Management Skills

• Analytical/Problem Solving Skills

• Ability to communicate verbally and in writing


Position Requirement

• Standing (__15_%)

• Sitting (__70_%)

• Walking (_15__%)

SAFETY TESTS

•Bloodborne Pathogen



Required Skills:



Preferred Skills:

Agility Jumps, Business Behavior, Compliance Management, Continuous Improvement, Database Backup, Data Gathering and Analysis, Data Savvy, Disruptive Innovations, Execution Focus, Issue Escalation, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

Skills Required

  • Bachelor's degree or equivalent in Engineering or a related technical or scientific field
  • At least 2 years of related experience
  • Basic knowledge of Quality Engineering and scientific methods and techniques
  • Basic technical understanding of manufacturing equipment and processes
  • Experience managing tasks or small projects and demonstrating project leadership abilities
  • Basic understanding and application of measuring techniques, including mechanical, optical, gage, or automation methods
  • Knowledge of production and processing systems
  • Knowledge of qualification and validation
  • Knowledge of product design support and product development support
  • Knowledge of quality statistics, data analysis, and related tools
  • Knowledge of product control and disposition
  • Knowledge of technical transfer and scale-up
  • Knowledge of predictive analytics and reliability
  • Ability to work in a stressful, fast-paced environment
  • Ability to collaborate with coworkers in a team environment
  • Management skills
  • Analytical and problem-solving skills
  • Verbal and written communication skills

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

Johnson & Johnson Insights

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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