Johnson and Johnson is currently seeking a Sr. Design Quality Engineer to join our team in Danvers, MA. 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/.   For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. The ideal candidate for the Senior Quality Engineer position will lead various Sustaining Engineering and New Product Development activities as well as play a role in product risk management, change controls, and design controls. This Senior Design Quality 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. Principle Duties and Responsibilities: + Support Lifecycle Change Requests for our Core Impella Product Portfolio + 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 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** + Must have in depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR. + Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971 is required. + 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. + 5+ years of work experience in a highly regulated industry is required, 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 international. + Experience conducting Process / Design Failure Mode Effects and Analysis is an asset. + Design control or new product development is preferred. + Experience supporting or conducting Process Verification / Validation activities is preferred. + Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques is an asset. This position will be based in Danvers, MA with a requirement to be on-site 3-4 days per week and will require 10% travel.(1-2 days remotely) Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.