QUALITY ENGINEER II, PRODUCT SOFTWARE DEVELOPMENT

DePuy Synthes Products Inc., a member of Johnson & Johnson Family of Companies, is recruiting for a Quality Engineer II, Product Software Development to be located in Boston, MA, Raynham, MA or Palm Beach Gardens, FL.
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.
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The Quality Engineer II, Product Software Development, provide quality oversight for new product project teams responsible for the development of medical device software systems.
The Quality Engineer assist in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! Key Responsibilities.
Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.
Provide assistance, guidance and expertise on the software development process, procedures and practices.
Partner with R&D to refine requirements, and to ensure that architecture/ design documents are comprehensive.
Facilitate the documentation and tracking of verification activities, including code review findings.
Review test case execution results and manage defects.
Facilitate software risk assessment sessions and own the development of risk documents.
Support regulatory filings and registrations Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.
Provide technical support for audits of software suppliers and software consultants.
Have knowledge of applicable industry standards and regulations including, but not limited to as IEC , FDA guidance, FDA Part 11, ISO, EU MDR, ISO, IEC .
Provide guidance and assist project teams, suppliers and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations.
Qualifications Education.
A Bachelor’s Degree received by May is required.
An Advanced Degree is preferred.
Focus degrees in Engineering, Computer Science, Information Systems, Biomedical/Bio-engineering Degree are preferred.
Experience and Skills.
Required.
A minimum of 1 year of experience in a regulated industry within a quality, new product development, or manufacturing engineering capacity.
Previous Coop and/or Internship experience will be considered.
Able to apply appropriate Quality tools/systems/processes to meet department goals and objectives Ability to effectively partner across functional areas Prioritize and run multiple projects while meeting deadlines/budgets Written and oral communication skills to meet departmental goals/objectives Knowledge of computer and Microsoft office tools such as Word, Excel and Power Point.
Preferred.
Medical device industry experience.
Other.
ASQ certification as a Software Quality Engineer, or equivalent, is preferred This position may require up to 10% domestic and/or international travel.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
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nj.
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