Business Segment: Healthcare Clinical Care Solutions
Location(s): India; Bengaluru
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE is an equal opportunity employer and supports Diversity.
Role Summary: The Lead System Designer (LSD) is responsible for Installed Base Engineering as a system owner across functions (Field, Manufacturing, Sourcing, Supply Chain, Vendors, sales & Service). Owns and manages the ‘product line’ till “EOL” to ensure that the product continues to ship and performs with good quality in the field. Contributes to system design activities of released products and directs a cross-functional team. Owns MS products and drives on timely closure change requests.
Essential Responsibilities: Duties include (but are not limited to): • Monitors quality of product, initiates corrective actions as needed • Owns & drive effective, on time closure with good documentations of CAPA, Investigations, FMI, NC, Complaints, SCR, ECR, Audit Observations, OBF, CSO, L4 cases • Owns the fulfilment risk management for the products that he/she owns • Ability to own and drive the change control management including reviews and timely closure of various change requests in a compliant manner. • Review and control the releases namely ER’s, MR’s and ECO’s • Works with CHU on complaints trending, SPCR coding and Investigations. • Conducting reviews to process the Supplier & Engineering change requests & routing the review output for approvals. • SPOC for the modality SCR’s and ensure all these are addressed on time. • Verify and validate the engineering change implementations including process, documentation, following appropriate approval matrix and ensure all the QMS goals are met • Manages part obsolescence issues pro-actively and initiates maintenance projects as needed • In addition to change responsibilities, drive the electrical test and verification activities related to MS products • Support all the QMS relevant audits. • Owns regulatory requirement & Drives other Sustaining Engineering projects (Ex: SCRs/ECRs, RoHS, UDI, Country Registrations, Labeling requirements) and deliver results on time. • Identifies Product Cost Reduction opportunities and proposes technical solutions to execute • Identifies technical unknowns and risks, creates mitigation plans and works closely with LPI and cross functional teams to mitigate them. • Ensuring that projects and processes abide to the business Engineering Quality Procedures, Phased Review Discipline, Supplier Transfer Work Instructions and regulatory needs of the applicable markets. • Developing strong stakeholder relationships and working with cross-functional teams, to drive Product, System, Interop & technology on-time and within spec • Working with functional managers to ensure right design quality within each function • Bring in Electrical and Electronics Design Experience to the Variable Cost Productivity (Product cost reduction) programs. • Design Change Management – Implementing design changes for cross functional effectiveness. Transfer of designs to manufacturing teams and service teams to implement in production and post market service operations.
Qualifications/Requirements: 1) Bachelor's Degree in Engineering 2) 6+ years’ experience in Software and hardware design (electrical and electronics) within a engineering, development, research or manufacturing environment. 3) Demonstrated ability to build lasting cross-functional relationships, including strong influential, communication, Documentation and collaboration skills. 4) Demonstrated understanding/experience with the product life cycle, transfer programs, product cost reduction programs or other productivity projects. 5) Highly developed problem solving skills 6) Experience working with foreign and domestic regulatory agencies 7) Experience in Electrical and Electronic solution designs
Quality Specific Goals: 1) Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2) Complete all planned Quality & Compliance training within the defined deadlines. 3) Identify and report any quality or compliance concerns and take immediate corrective action as required. 4) Ensure compliance/closure of Regulatory and Quality requirements before approving technical and program milestones. 5) Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives. 6) Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible
Desired Characteristics: 1) Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program 2) Previous healthcare experience developing products within an FDA regulated environment 3) Hands on software design experience in a IB product development environment Knowledge of GE Healthcare engineering tools and processes (EQPM, ePDM) 4) Knowledge of GE Healthcare tools and processes (engineering, sourcing, supply chain) 5) Strong written and verbal communication skills 6) Demonstrated success with conflict resolution Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues 7) Change Control Management experience 8) Medical device design and support experience 9) Expertise with Electrical Design, single board computer and embedded device design and support 10) Working knowledge of ISO, FDA and other applicable medical device regulatory standards 11) Familiarity with GEHC MS products 12) Demonstrated success leading global technical project teams 13) Attention to detail and ability work with global cross-functional teams toward timely completion of a variety of assignments
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