Johnson & Johnson Careers
Senior Analyst - Service Specialist, Software as a Medical Device (SaMD)
West Chester, Pennsylvania; Warsaw, Indiana; Cincinnati, Ohio
Requisition ID: 4911190121
Johnson & Johnson is currently recruiting for a Senior Analyst - Service Specialist within its Software as a Medical Device Build group. This position will be based out of West Chester, PA; Warsaw, IN; or Cincinnati, OH.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every single day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Johnson & Johnson recognizes that technology is the future of health care and recruiting strong talent to help lead our company into that future is key. The Senior Analyst will be a member of the Software as a Medical Device(SaMD) build team whose responsibilities include consulting with business partners to help capture and steer requirements, translating those requirements into solutions, developing alternative solutions, and providing schedule and budgetary estimates. Those solutions then need to materialize into specific technical systems/applications or process designed for our internal and external users. A key component is also working with and influencing multi-functional teams within IT, business partners and vendors on the right solutions and ensuring that the service and solutions are delivered at or exceeding our users expectations.
Additional responsibilities include supporting the SaMD Regional Service Owner (RSO) to drive continuous improvement of the SaMD build service offering, managing all supporting services provided by other groups within J&J Technology, communicating SaMD technology, product, and business concepts to all partners and suppliers. Our goal is to provide compliant, innovative solutions that follow the J&J processes. To do this we will need to create and track metrics to continuously improve as our organization matures. If you like working in a very new, complex, and challenging environment that directly impacts the live of patients and healthcare professions, then this position is for you.
- Lead delivery of the service offerings with other utilized service offerings from Application and Infrastructure teams. This includes working with the business to steer requirements, develop solution alternatives, estimates and translating client business requirements into platforms and process designed specifically for SaMD solutions. This also includes negotiating scope and leading changes with users, other services and vendors.
- Address issues and challenges pertaining to the offering, and expediting / resolving issues that may require partnership across the organization.
- Ensure compliance with current and future regulations, policies and standards of governing and select standards bodies (i.e. FDA, IMRDF, TUV, ISO) while adhering to J&J standards including Agile, SDLC, and Portfolio Management.
- Collaborate with the RSO creating, tracking, and adjust metrics for the perpetual improvement of the overall quality, speed and value to the Business Partner.
- Collaborate across Application Services to identify, communicate and resolve integration issues between services. Connect enabling teams such as the development centers, professional services support center, and other service-based teams, to ensure a positive overall offering delivery experience for customers.
- Collaborate with the business, internal AS partners, and AS leadership to shape selection and management strategies for both technology and professional services to ensure the best possible deliverable for the lowest possible price with the fastest speed to market.
- Ensure projects meet or exceed established metrics. Work with RSO to define and refine metrics.
- A minimum of a Bachelor’s Degree or equivalent is required.
- A minimum of 5 years of related work experience is required.
- A minimum of 5 years of experience working in highly matrixed large enterprise organization is required.
- Solid grasp of Product Life Cycle Management or similar systems is required.
- Understanding of FDA SaMD guidelines (510K, etc.), IMDRF (SaMD WG(PD1)/N41), ISO (13485, etc.) is preferred.
- Previous experience with orthopedics, medical device, pharmaceutical clinical trials, etc. is preferred.
- Familiarity with software validation is preferred.
- Experience and/or knowledge of IT infrastructure, security protocols and processes is preferred.
- Experience with full Software Development Lifecycle methodologies including Agile/Scrum is preferred.
- Strong verbal and written communication skills, enabling effective interaction with teams located in different regions/countries is required.
- Ability to understand and document highly complex/technical solutions is required.
- Having adept analytical and problem-solving skills are required.
- Strong planning, organizational, and decision-making skills are required.
- Experience defining, shaping, and driving projects to completion while effectively collaborating with partners is required.
- Experience solving complex business problems and presenting recommendations to management effectively is required.
- This position is located in West Chester, PA; Warsaw, IN; or Cincinnati, OH and may require up to 10% 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.
United States-Pennsylvania-West Chester-
North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati
Johnson & Johnson Services Inc. (6090)