HireDiversity

West Chester, PA, US

Staff Firmware Engineer-7396121128

Description

Animas Corporation, a member of the Johnson & Johnson Family of Companies, is recruiting for a Staff Firmware Engineer that will be located in the West Chester, PA.

Animas Corporation develops and manufactures glucose management systems that help people living with diabetes better manage their disease and live a life without multiple daily insulin injections. Animas is dedicated to helping make diabetes management easier through exceptional customer support, educational programs and product innovation. Many of the people who work at Animas are either living with diabetes or are a first-degree family member of someone living with diabetes, so it's no surprise that the company has led the way in insulin pump innovations since its first pump launched in 2000. To learn more visit www.animas.com.

Reporting to the Manager, R&D, Development and Sustaining, the Staff Firmware Engineer is responsible for architecture, design, project planning, and design/development coordination activities for software projects within the insulin delivery group. Typical focus of activities will be in the area of core architecture & design for new platforms, product development and revisions/failure mode analysis on legacy designs. Regularly interfaces with members of product development, supply chain, QA, regulatory, marketing and legal as well as technical professionals within the Diabetes Franchise. They may oversee projects utilizing outside development services.

The incumbent is responsible for embedded software systems design and architecture for new and existing platforms. They also must handle the development of complex sophisticated software controlled electromechanical medical devices, requirements definition, design review and input to software validation activities. They should have experience in outsourced medical device software development, a strong understanding of medical device regulations including FDA GMP, design controls, ISO13485, regulatory audits and international environmental regulations.

A successful candidate maintains active, regular communication and involvement with internal and external project team members and contract manufacturers. The must establish and implement process for best practices for needed emerging standards and regulations. The incumbent must possess strong knowledge of digital design electronics, microcontrollers and sensors, and a record of creating detailed design documentation with a focus on standardization, and engineering discipline. In addition, they lead diligence on functionality and differentiation, and provide root cause analysis in the support of product liability litigation.

Qualifications


A BS degree with a minimum of 7 years of relevant experience, or a MS degree with a minimum of 5 years of relevant experience, or a Ph. D with a minimum of two years of relevant experience is required. Experience with medical device regulations including ISO13485, FDA requirements specification and design control process, verification/validation activities, IEC 62304 (Medical device software - Software life cycle processes) as well as current standards in software controlled medical devices is required. Candidate must be an independent, innovative, tactical and strategic thinker with background and experience in the design of Class II/III embedded medical device software systems. Candidate must have excellent problem solving and analytical skills. Must be fluent in code design tools, C, C++, assembly code, real time operating systems, embedded systems design with a demonstrated track record of developing and launching sophisticated software controlled medical devices.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Animas Corporation (6150)
Job Function: R&D Engineering (R&D)