Senior 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 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 Senior Design Quality Engineer to join our Abiomed 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 Senior Design Quality Engineer position will support various New Product Development activities as well as play a role in product risk management, change controls, 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 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).

Qualifications 

Education:

• A minimum of a Bachelor's degree is required. Degrees in an engineering or scientific discipline are preferred. An advanced degree in a related field is also an asset.
   

Experience and Skills

Required:

• A minimum of 5 years of related work experience.
• Working knowledge and practical application of quality system regulations, 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:

• Ability to communicate id