IoT Quality Management System Engineer
New Brunswick, NJ

Job Description

Johnson & Johnson is currently recruiting for an IoT Quality Management Systems (QMS) Engineer. This position must be located at in Mountain View, CA; Cincinnati, OH; Somerville, NJ; or New Brunswick, NJ.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Medical Devices represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD organization supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

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.

THE OPPORTUNITY

The IT R&D Product Innovation group's mission is to reach more patients and restore more lives by innovating and enhancing Johnson & Johnson's medical device products. We are looking for a hardworking IoT QMS Engineer to drive our new Internet of Things (IoT) capabilities for Digital Surgery. The ideal candidate will have an entrepreneurial mindset, excellent communication skills, and comfortable translating complicated regulatory concepts into easy to understand language. The candidate can manage complex systems with interlinking dependencies across multiple IoT solutions, passionate about solving complex problems, and well-adapted in best practice design disciplines. We invite you to become part of a team that is breaking new ground in the ways J&J builds IoT solutions.

RESPONSIBILITIES:

* Utilize system thinking principals to organize the interlinking requirements and software modules that encompass the IoT solutions
* Collect, maintain, and manage requirements and traceability for the IoT solutions
* Work with Agile SCRUM teams to complete the Design History File (DHF)
* Craft the testing and evaluation strategies to qualify the environments - including the identification and qualification of edge-based testing tools
* Responsible for risk management and failure mode analysis (FMEA)
* Partner with SMEs to collect and manage patient data privacy requirements such as High Trust, HIPPA, GDPR, etc.
* Build and institute new design processes to ensure best practices are followed
* Identify and manage the "external standards" qualifications required for hospital environments as needed - e.g., electrical safety, EMC
* Work with medical device software engineers to identity the engineering requirements, testing needs, and traceability artifacts required for the design history file of the medical device
* Partner across multiple operating segments including application development and Cybersecurity to realize the IoT vision
* Partner with the R&D Product Development organizations to understand their IoT needs, help prioritize investments, develop use cases, generate processes, and develop overall solution requirements including application definition, integration, security, and system configurations
* Provide technical and thought leadership for the development and integration of new IoT solutions
* Lead teams, manage project schedules and launch creative new connected medical device products following SDLC processes

Qualifications

* Bachelor's Degree required in IT or related Engineering field; Master's Degree in IT or related Engineering field is preferred
* Strong knowledge of software development or engineering processes is required
* Demonstrable project experience managing requirements, risk management, and verification and validation is required
* Familiarity with FDA Design Controls or GxP requirements is required
* Experience leading, managing, and delivering projects is required
* This position must be located at in Mountain View, CA; Cincinnati, OH; Somerville, NJ; or New Brunswick, NJ
* IoT project experience strongly preferred
* Up to 20% travel, domestic and international is required

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.

Primary Location

United States-New Jersey-New Brunswick-

Organization

Johnson & Johnson Services Inc. (6090)

Job Function

Info Technology

Requisition ID

3045190429