Design Quality Engineer II

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Warsaw (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Johnson & Johnson is recruiting for two Design Quality Engineer II positions in Warsaw, IN. This role applies quality engineering methods to daily tasks and supports product design and process development within DePuy Synthes' orthopaedics framework.

You will work under guidance to implement risk management, lead root-cause investigations, and ensure process controls meet regulatory and company standards. A bachelor’s degree in engineering and 2+ years of related experience are required.

Qualifications

• Bachelor’s degree in Engineering or related field AND 2+ years related experience.
• Basic knowledge of Quality Engineering/Scientific methods.
• Technical understanding of manufacturing equipment and processes.
• Experience managing tasks or small projects and leadership abilities.

Responsibilities

• Demonstrates competency to apply Six Sigma/Lean tools for improvements.
• Supports risk management and mitigation activities.
• Contributes to reliability assessments of product design.
• Contributes to root-cause investigations and corrective actions.
• Develops test methods for equipment, process, and product qualifications.
• Ensures process quality control plans are followed with risk levels.
• Maintains production/process controls and quality metrics.

Skills

Production Systems

Qualification & Validation

Product Design Support

Quality Statistics

Data Analysis

Product Control

Product Development

Tech Transfer

Predictive Analytics

Education

Bachelor’s degree in Engineering

Job description

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 | 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

• 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

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 https://www.jnj.com/. 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. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information