Staff SDLC 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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Digital Quality

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Milpitas, California, United States of America, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, San Angelo, Texas, United States of America, Santa Clara, California, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

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

Johnson & Johnson is recruiting for a Staff SDLC Engineer.

This is a hybrid role available in all J&J MedTech hubs within United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

The Staff SDLC Engineer primarily supports the MedTech QS/DS organization’s effort to drive MedTech wide Digital QMS Program and independently drive QS automation, technology/solution deployment, validation and PLM configuration management projects.  This position will primarily lead planning and execution of SDLC and Non-Product Software (NPS) Validation while providing the guidance needed to ensure compliance with the company’s Quality System policies, procedures and applicable external requirements and standards.

Key Responsibilities:

• Provide SME support to MedTech NPS teams in planning and development, validation and change management of GxP software solutions.
• Develop, execute, and oversee validation plans, strategies, and reports for GxP software solutions.
• Support MedTech Digital Asset Management governance process through Compliance Assessment and providing operational assistance and training.
• Leads value-driven prioritization of improvement opportunities, lead continuous improvement projects by working by working with cross functional teams.
• Understand business partners and stakeholders’ needs and translate into GxP solutions while balancing tradeoffs and business impact.
• Participate in J&J Enterprise Level effort around MedTech Software standards and technology deployment as an SME, such as  multi-functional teams to integrate IT solutions to optimally meet the requirements of the MedTech Digital QMS.
• Supervise contract resources and mentor GROW resources to achieve milestones on time and develop the less seasoned high potential talent to build continuous talent pipeline.
• Develop and maintain standardized procedures, work instructions, knowledge articles needed for implementation of solutions and changes within the scope of work.

Qualifications

Education:

• A minimum of a Bachelor degree is required; a degree concentration in Computer Science, Engineering, Life Sciences, Data Science or related field is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of work experience in MedTech and software business (any combination of ISO 13485, FDA CSA, GAMP5, and Part 11 – or similar regional equivalent i.e. FDA).
• Strong communication, collaboration and social skills to engage partners, build an environment openly entertain new ideas/solutions, lead discussions to align objectives across partners and gain their consensus.
• Capability to build a consensus and leading collaborators through process, technology solution, or organizational change.
• Ability to articulate cerebral or ambiguous ideas and observations into clear set of problem statements or solutions.
• Strong project management skill.
• Solid understanding of software, system or technology solution development and lifecycle management is required.
• Flexible with the ability to work independently as well as on teams with excellent time management skills to balance multiple projects.

Preferred:

• Hands on work experience in Q&C experience in Software development using modern tools (i.e. Jira/Xray, Bitbucket, Jenkins, Sonarqube, Polarion, Cognition, etc) preferred.
• Hands on work experience with modern RPA, AI/ML, and other automation technology platforms, solutions, or languages such as Microsoft Power Platform, Power Fx, Python, Java, R, etc.
• Hands on work experience in Digital Asset Management as Software Quality Engineer in terms of Compliance Assessment inclusive of risk assessment of GxP, Security, Privacy, Records Retention, etc..

Other:

• Up to 10% travel, regionally and internationally required.
• This role will be based out of J&J MedTech sites in the US West Coast Timezone to provide adequate timezone coverage for the teams we support, including APAC teams.

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$91,000 to $147,200. At the bay area, $105,000 to $169,050.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits