Medtronic
Location
Secunderabad | India
Job description
Lead and/or act as a SME for investigations of root causes for a wide range of issues, including but not limited to aspects of electrical, mechanical, software/firmware, systems, user-related, or manufacturing.
Assess supplier driven changes, component changes, and component obsolescence for potential impact to products.
Review and analyze circuit schematics, printed circuit boards, and technical specifications.
Define system/device requirements, interface requirements, and traceability.
Create verification and validation plans/protocols, test method validations, and reports.
Assess the impact of changing standards on existing products and assess the impact of changes in medical products against existing standards.
Plan, schedule, manage activities for design changes, remediation projects, or programs.
Drive tasks with internal and external development partners, manufacturers, and suppliers.
Quickly react and resolve issues based on changing priorities to assure quality and continuity of supply.
Champion consistent implementation of the Quality System and advocate for best practices and continuous improvement.
Effective in written and oral communication; experienced in report writing and effective presentation skills
PRINCIPAL WORKING RELATIONSHIPS
The incumbent would work with the project team at MEIC
Frequent interaction with team members from other disciplines, cross functional teams, to understand project requirements and to adhere to project deliverables & schedules.
Possible interaction with third-party vendors, contract manufacturers, and subcontractors.
Must Have: Minimum Requirements
Bachelor s Degree in Electrical Engineering or equivalent with 8 to 12 years of Relevant experience in Electrical product life cycle management.
KNOWLEDGE, SKILL, AND ABILITY
Broad technical skills in the Electrical and Electronics Engineering
Willingness to work in a continuation & Release product engineering role.
Experience in a controlled environment, preference to previous medical device experience. Working knowledge of applicable IEC/ISO standards (IEC 60601, ISO 14708, etc.) a plus
Bachelor of Electrical and Electronics Engineering with a strong focus in electronics Strong knowledge of Engineering fundamentals and application
Familiarity with product development processes in a regulated industry
Medical Device development experience
Experience with EMC design and testing
Expertise in use of common lab equipment (oscilloscopes, DVM s, etc.)
Experience with Altium ECAD tools
Understanding and/or experience with risk analysis processes and tools (FMEA s, hazard analysis, etc.)
Working knowledge of applicable IEC/ISO standards (IEC 60601, ISO 14708, etc.)
Familiarity with EOL, Obsolescence management and sustenance activities
Able to effectively work with cross functional teams in a multinational matrix organization
Superior written and verbal communication skills required.
Good attitude and team player.
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