Software Test Engineer - Enabling Tech R&D

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

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Software Test Engineer - Enabling Tech R&D to be in Warsaw, IN.

The Software Test Engineer will test, verify and validate software systems to maintenance and bring to market products of the highest quality and commercial potential. The Software Test Engineer will work alongside others on multiple software development teams to align on a meticulous development approach. The Software Test Engineer will be the subject matter expert, defining and executing test strategies, and the voice in development teams for testing and quality.

SECTION 2: DUTIES & RESPONSIBILITIES*

• Writing and executing test cases ensuring that they meet provided requirements and acceptance criteria
• Ensure the consistent use of our Quality Management System tools and to document Software Verification Protocols and test results
• Follow and adhere to the best-practices of software test engineering, QA practices and processes in the organization.
• Provide peer review of technical and verification documents
• Ability to work effectively in a collaborative agile team environment
• Effective testing of applications during the Software Development Lifecycle including design, implementation, and execution
• Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products. 
• Provide leadership, 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. 

• Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, IEC 62366. 
• Know, understand, incorporate and comply with applicable laws and regulations relating to Depuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. 

SECTION 3: EXPERIENCE AND EDUCATION*

• A Bachelor’s Degree is required.
• A minimum of 3 years of experience in technology, software development and testing is required.
• Familiarity with regulations such as IEC 62304 and ISO 14971 and other FDA guidelines is required.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Education:

• Bachelor’s Degree or higher

Required Qualifications:

• Experience testing complex software applications, human-machine interaction systems is required.
• Experience working with software product development teams is preferred
• Demonstrated ability to synchronize, and motivate personnel both within and outside immediate control to meet goals and objectives
• Experience with reviewing and revising verification plans and input requirements is preferred.
• Familiarity with common programming languages such as C++, C#, and Python is preferred.
• Experience using a tool or repository for managing test cases (Polarion, JIRA, JAMA etc) is a plus.
• The ability to utilize written and oral communication skills to meet departmental goals/objectives is required.
• Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required.
• Medical device industry experience.

Preferred Qualifications:

• Software as a Medical Device (SaMD) experience is strongly preferred.
• ASQ certification or equivalent, is preferred

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

 Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource