Lead Systems Engineer at Medtronic

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

10 to 13 years of experience with validation of test methods, hardware and software, test fixtures
Extensive technical knowledge and expertise in Design of Experiments, Measurement system Analysis, Test Method Development, Root Cause Analysis, Capability studies, Fixture Qualification, Statistical process control, Risk Management & Non-Product software validation
Well-versed in verification and validation methodologies, industry standards, and best practices
Knowledge of principles and applications of biomechanics, physics, mechatronics, and electrical, mechanical and software development
Experience writing technical reports for the medical device industry
Solid understanding of Design Controls, Medical Device Design Verification, and GDP (Good Documentation Practices)
Experience in Minitab, MATLAB or LabVIEW and Python
Required: B.E or B. Tech in Mechatronics, Mechanical, Electronics or Electrical
Preferred: M.E or M. Tech in Mechatronics, Mechanical, Electronics and Electrical
Strong technical leadership skills to guide and mentor team of engineers
Strong System Verification & Validation skills
Strong knowledge on tools and technologies
Problem solving capabilities

Responsibilities

Leverage extensive expertise in Design of Experiments, Test Method Development, Root Cause Analysis, Statistical Process Control, and Risk Management to ensure system reliability and compliance
Focus on verification and validation processes, fixture qualification, and adherence to industry standards and best practices
Work closely with cross-functional teams, including design engineers, project managers, and quality assurance teams, to ensure seamless integration of verification and validation activities into the overall development process
Develop and Validate HW/SW Fixtures and demonstrate high-quality standards
Write validation protocols and reports based on requirement inputs
Maintain comprehensive documentation of all verification and validation activities, including test plans, test results, drawings and reports
Provide regular updates and reports to stakeholders and management
Responsible for the end-to-end process involved in demonstrating the System meets our product requirements
Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the verification and validation process
Effectively communicate with internal teams and external stakeholders, providing technical insights and updates on verification and validation progress
Participate in the documentation, communication, and review of undesirable test outcomes, and/or design enhancements, and determine impact of changes to test plans
Frequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules
Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors, and other users

Skills

Key technologies and capabilities for this role

Design of ExperimentsMeasurement System AnalysisTest Method DevelopmentRoot Cause AnalysisStatistical Process ControlRisk ManagementFixture QualificationCapability StudiesVerificationValidationNon-Product Software Validation

Questions & Answers

Common questions about this position

What experience level is required for the Lead Systems Engineer role?

The position requires 10 to 13 years of experience with validation.

What key technical skills are needed for this position?

Candidates need extensive expertise in Design of Experiments, Measurement system Analysis, Test Method Development, Root Cause Analysis, Capability studies, Fixture Qualification, Statistical process control, Risk Management, and Non-Product software validation.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What leadership qualities are expected in this role?

The role requires strong technical leadership skills to guide and mentor a team of engineers involved in the system verification and validation process.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees