Senior Systems Engineer (Intel-GE Care Innovations) in New York

Job Title: Senior Systems Engineerbr/
Company: Intel-GE Care Innovationsbr/
Location: New York, NYbr/br/

Intel-GE Care Innovations™ creates technology-based solutions that give people confidence to live independently, wherever they are. We are a unique joint venture between Intel Corporation and GE, based on a long history of driving innovation, solving hard problems, and creating new markets. Today, we deliver products and services to support current and future care models in three core areas: disease management, independent living and assistive technologies. Visit a href=http://www.careinnovations.com target=_blankwww.careinnovations.com/a to learn more about our company.br /
br /
bSenior Systems Engineer/bbr /
br /
The Senior Systems Engineer will play a critical development and leadership role within the QuietCare Engineering department of the Care Innovations Product/Service Lifecycle organization. This vital position is responsible for the definition and implementation of the Systems Engineering processes/capabilities, ensuring that a Systems Engineer lead role is implemented properly for each development program and executes as the technical lead for key development activities. The Senior Systems Engineer will partner with the Engineering, Development Controls, and Quality System teams to ensure efficient and effective development processes and will work closely with the Program Manager to ensure that the end product matches our customer’s expectations from a quality, capability, cost, and schedule perspective.br /
br /
The candidate in this role also will be involved in all phases of the product lifecycle process, including RD, product development, manufacturing, sustaining engineering/support, and systems infrastructure/deployment. Responsible for the technical definition, specification, systems engineering planning, and overall engineering execution for complex medical device and/or consumer device product development lifecycle programs, the Senior Systems Engineer will provide leadership on implementation of Good Manufacturing Practice throughout the product lifecycle and will contribute to sustaining engineering support for released products in the field, product deployment and infrastructure engineering for shared/hosted product components. They also will provide hands-on mentoring, leadership and direction for Junior Engineers and for the overall engineering organization, particularly in the areas of Quality Systems, regulatory compliance, and good engineering design practice. This position reports directly to the Director of QuietCare Engineering.br /
br /
The successful candidate will have demonstrated experience or capability in the following areas:br /
• Requirements of 21 CFR 820.30, ISO 13485, and other related medical device regulations.br /
• Product design, product development, project management, and medical device development under FDA and European Union regulations. br /
• Application of formal systems engineering methodologies (state the problem, understand customer needs, discover system requirements, validate requirements, investigate alternatives, define quantitative measurements, model the system, functional analysis, risk management, reliability analysis, integrate the system, project management) to complex programs.br /
• Integration of mechanical, electrical, optical and software solutions into components, subsystems, and systems.br /
• Engineering leadership of complex product through design, specification, development, and manufacturing under medical (or government) regulations.br /
• Quick turn prototyping to prove effectiveness of design or production fixes.br /
• Define and implement effective, yet simple and efficient Standard Operating Procedures and Instructions.br /
• Improve efficiency and reduce throughput time in complex engineering projects.br /
• Structured Requirements Analysis and Specifications Development.br /
• Create and maintain programmatic and technical documentation to ensure efficient planning and high quality execution.br /
• Manage and document complex system configurations.br /
• Think holistically and be a master at systems thinking. br /
br /
Multi-disciplinary capabilities are highly desirable; experience or qualifications in any of the following areas outside of the core job scope are desirable:br /
• Manufacturingbr /
• Product transition to manufacturingbr /
• Customer Support Operationsbr /
• Deploymentbr /
• Sustaining Engineeringbr /
• Software Engineeringbr /
br /
bQualifications/bbr /
br /
• Bachelor’s degree (Master’s preferred) in Engineering or related field.br /
• 10+ years experience in the design, development and implementation of integrated medical (or military) systems.br /
• 5+ years experience in an ISO13485 and/or ISO 9001 QMS environment.br /
• 5+ years experience in the application of ISO 14971 Risk Management.br /
• Excellent interpersonal skills, writing and presentation skills, in small and large group settings. br /
• Proven skills in problem solving, negotiation, and diplomacy.br /
• Familiarity with GMP, Statistical Analysis Techniques, FMEAs, MTBF calculations and advanced quality engineering tools.br /
• Experienced in the use of system requirement and specification software preferred.br /
• Experience with engineering tools such as Minitab and/or other statistical analysis preferred.br /
• Experience with systems developed and deployed on a Linux OS platform preferred. br /
• Experience with hosted software-as-a-service product development preferred. br /
br /
bJob Location/bbr /
br /
• This position is located in the New York City area.br /
• Ability to travel up to 10% of the time to other company locations and customer/partner sites is required. br /
• Relocation will be approved on a case by case basis.br /
br /
bBenefits/bbr /
br /
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive salary and an extensive benefits package including paid time off, medical, dental and vision benefits, 401K with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.br/br/

bHow to Apply/bbr/br/

To respond to this opportunity, please go to: br /
a href=https://insperity.ats.hrsmart.com/cgi-bin/a/highlightjob.cgi?jobid=72585 target=_blankhttps://insperity.ats.hrsmart.com/cgi-bin/a/highlightjob.cgi?jobid=72585/abr /
br /
EOEbr/br/

Source: a href="http://www.engineerjobs.com/jobs/mechanical-engineering/"Mechanical Engineering Jobs/a at Engineer Jobs.com

This position, Senior Systems Engineer (Intel-GE Care Innovations) in New York, was posted on January 29, 2012. The job is located in New York. Since this job has been published, it has been viewed 25 times.