Design Quality Engineer

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 Med Tech, 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

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.

Quality

R&D/Scientific Quality

Professional

Danvers, Massachusetts, United States of America

We are searching for the best talent for Design Quality Engineer role to join our Med Tech Quality organization located in Danvers, MA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at

• Support New Product Development projects Risk Management Deliverables
• Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients
• Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include design for manufacturing, assembly, and automation
• Develop and/or review test protocols, reports, and engineering summaries
• Perform process development studies in collaboration with cross functional teammates and bring an open mind to design solutions which enable manufacturability internally and at external suppliers
• Test and analyze engineering prototypes using statistical analysis in Minitab and apply to the design effort (Multivar chart, t-tests, confidence/reliably analysis, Gauge R&R) to iterate concepts toward extremely innovative yet robust solutions
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities
• Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
• Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary
• Support 3rd party audits, including follow-up on actions
• Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP)

• Education:
  
  A minimum of a Bachelor's degree is required. Degrees in engineering or scientific discipline is preferred. An advanced degree in a related field is also an asset
• Required
  
  Experience and Skills:
  
  A minimum of 6 months of related work experience ;
  Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, QSR, ISO 13485, MDSAP and/or MDD/MDR ;
  Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international
• Preferred
  
  Experience and Skills:
  
  Work experience in a highly regulated industry ;
  Experience conducting Process / Design Failure Mode Effects and Analysis ;
  Design control or new product development experience ;
  Experience supporting or conducting Process Verification / Validation activities ;
  Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques
• Other:
  This position will require to work onsite in Danvers, MA with a minimum of 4 days per week and will require 10% of domestic and/or international travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation,…