Medtronic is an Equal Opportunity/Affirmative Action Employer
Provides technical engineering expertise and leadership to the Supply Management organization and suppliers. These responsibilities may include: establishment of supplier process
control plans; support of new product development teams; leadership of certification efforts; lean and six sigma continuous improvement with suppliers; partnering with product
development engineering to ensure linkage with commodity strategies in terms of proper supplier and component selection; and driving Design for Manufacturability and Reliability processes. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program
in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and
quality standards are met. Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.
Facilitates of continuous improvement with suppliers, support and/or implementation of structural Early Supplier Involvement (ESI) process in new product development to achieve
Design for Manufacturability and Reliability.
Identifies of key technical capabilities of supply base; establishment of control plans and monitoring systems for supplier processes.
Identifies and manages risks associated with low margins between supplier processes and design requirements.
Facilitates and reports the progress of supplier corrective actions as assigned by relevant CAPA system.
Provides core team input of Design for Sourcing/Manufacturability into new designs, long term technology/supplier scanning for product/technology road maps.
Provides regular communication updates to management on status of supplier issues
Owns technical aspects of a family of components or material commodities
Projects leadership of cross-functional teams to drive root cause and final resolution of supplier recovery related issues.
Executes activities involving contractual actions with supplier
Trends supplier performance and drives effective corrective and preventative action.
Develops technical solutions to problems using the corrective/preventative action process including reviewing and resolving non conforming material issues
Owns the execution of Supplier Process Change Notification including re-qualification needs and review of change for possible affects to downstream manufacturing customers
Leads and executes Supplier Process Audits – will work with Quality regarding process controls and capabilities
Develops and maintains inspection procedures for components and materials to support receiving inspection, manufacturing and development.
Performs other position duties as assigned.
Reports any observed or informed process and/or product non-conformities to the Supervisor.
Finds resolution of Quality Situations at the area of responsibility.
Reports any complaint regarding a Medtronic product to the Supervisor.
Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.:
FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR’s).
Acknowledge and maintain commitment with the EHS Policy.
Participate in the development of EHS improvement projects.
Participate actively in the EHS programs to achieve the objectives and targets defined for the area.
Engineers in Projects:
Ensure that the EHS considerations, legal and corporate requirements and efficiency indicators are included in new project design and project evaluation in order to maximize the
cost/benefit ratio and minimize the EHS impacts and risks.
Ensure that EHS performance indicators are included in the selection process of contractors.
Evaluate and re-evaluate periodically the EHS performance of contractors and sub-contractors.
Supervise that contractors perform their job in accordance to the EHS requirements in order to reduce, minimize or prevent EHS impacts and risks.
Maintain current knowledge of the potential EHS aspects and risks of new projects.
Educational: Engineering or Science of Engineering (except civil) or related field.
Experience: Senior Level: 5+ Years with Bachelors or 3+ Years with Masters
EIT licensed and active member of CIAPR
Exposure to engineering and manufacturing environment
Quality and Results Oriented
Fluency speaking and writing in English and Spanish
Experience in medical device, pharmaceutical, or electronic industry
Root Cause Analysis
Technical Writing and Composition
Physical Job Requirements
Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document.
Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal
Work is performed in building’s interior with normal temperature, good illumination, air condition, clean environment and minimum risk
Medtronic - 22 months ago
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...