Lead Systems Engineer

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Lead Systems Engineer leverages extensive expertise in Design of Experiments, Test Method Development, Root Cause Analysis, Statistical Process Control, and Risk Management to ensure system reliability and compliance. This role focuses on verification and validation processes, fixture qualification, and adherence to industry standards and best practices, driving high-quality outcomes for complex systems.

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 & Non-Product 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

• 10 to 13 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 Electronics or Electrical.
• Preferred: - M.E or M. Tech in Mechatronics, Mechanical, Electronics and Electrical.
  
  
  

Short-Term Success Metrics (6-12 Months)

• Demonstrate strong System Verification & Validation skills
• Demonstrate strong knowledge on tools and technologies
• Establish trusting relationship with the team and other stakeholders
• Demonstrate problem solving capabilities.
• Deliver on project commitments.
  
  
  

Long-Term Success Metrics (1+ Year)

• Learn and demonstrate Product and Domain understanding
• Demonstrate solid understanding of Product Development Lifecycle
• Consistently deliver on Project commitments
  
  
  

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here

---