Senior System Engineer

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

A Day in the Life

The Systems Engineer will be a key member of the R&D team, contributing to the development and support of medical devices. This role requires extensive expertise in Design of Experiments, Test Method Development, Root Cause Analysis, Risk Management, and statistical tools like Capability Studies and SPC. The candidate will apply technical knowledge in verification, validation, and industry standards to solve engineering challenges and ensure compliance with best practices.

Job Description

Responsibilities may include the following and other duties may be assigned Essential Duties and Responsibilities

• Expected to have 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 & NonProduct software validation. Should be well-versed in verification and validation methodologies, 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.
• Shall poses strong technical leadership skills to guide, and mentor team of engineers involved in the system verification and validation process.
• Shall 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.
• Shall drive continuous improvement initiatives to enhance the efficiency and effectiveness of the verification and validation process.
• Shall 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

Principal Working Relationships

• Reports to the Sr. Engineering Manager/Engineering Manager
• Accountable to Project Manager(s) for project-related responsibilities
• 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.

Experience

8 to less than 12 years of experience with validation of test methods, hardware and software, test fixtures.

Knowledge, Skill, And Ability

• Experience with validation of test methods, hard and software, test fixtures.
• 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

Education

• Required: - B.E or B. Tech in Mechatronics, Mechanical or Electrical.
• Preferred: - M.E or M. Tech in Mechatronics, Mechanical and Electrical.