Design Quality Engineer II

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:

Danvers, Massachusetts, United States of America

Job Description:

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

About MedTech

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 https://www.jnj.com/medtech
 

The ideal candidate for the Quality Engineer position will lead various New Product Development activities as well as play a role in product risk management, manufacturing qualifications, and design controls.
 

This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.
 

Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech.  Come join our Abiomed team today!

Key Responsibilities:

• Support New Product Development projects for our Impella product portfolio, emphasizing on Risk Management. 
• 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 MFG 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).

Qualifications:

• A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
• Must have in depth knowledge of and ability to apply quality system regulation, including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EU MDR and others.
• 2+ years of work experience in a highly regulated industry is required or equivalent masters degree in engineering or scientific discipline. Medical Device and/or Pharmaceutical industry is preferred.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and