We anticipate the application window for this opening will close on - 20 Jun 2025

 

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 Design Assurance Engineer plays a vital role in ensuring products are safe, effective, and meet regulatory and quality requirements during the design and development stages. This role is essential for delivering high-quality, safe, and effective products to the market while maintaining compliance with industry standards.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

Responsibilities may include the following and other duties may be assigned.

• Quality Planning: Partnering with cross-functional teams to establish quality plans and ensure compliance with regulatory standards (e.g., FDA, ISO).

• Design Verification & Validation: Supporting or leading activities to confirm that the product meets design inputs and user needs through rigorous testing and validation.
• Process Oversight: Ensuring adherence to design control processes, including traceability of requirements, design reviews, and design history file documentation.
• Regulatory Compliance: Collaborating with regulatory teams to ensure designs meet global regulatory and quality standards.
• Problem Solving: Investigating and resolving design-related quality issues by working closely with engineering, manufacturing, and quality teams.
• Continuous Improvement: Providing feedback and recommendations to improve design processes and product reliability.
• Documentation: Maintaining and reviewing quality documentation to ensure accurate and comprehensive records for regulatory submissions.

Qualifications

Must-Have: Minimum Requirements

• Requires a Baccalaureate degree
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

Nice to Have

• Experience with ISO 13485, FDA Quality System Regulations (21 CFR Part 820), and EU MDR/IVDR Compliance:
  Familiarity with global regulatory requirements and standards for medical devices to ensure compliance throughout the product lifecycle.
• Knowledge and/or Experience with Software Development and Deployment:
  Understanding of software development processes (e.g., Agile, Waterfall) and deployment practices, including DevOps principles and IEC 62304 compliance for medical device software.
• Proficiency in Model-Based Systems Engineering (MBSE) and Digital Twin Methodologies:
  Experience utilizing MBSE tools to enhance system design, integration, and validation workflows.
• Expertise in Statistical Analysis and Six Sigma Methodologies:
  Strong skills in statistical tools (e.g., Minitab, JMP) and Six Sigma methodologies (Green/Black Belt certification preferred) to support process improvements and data-driven decisions.
• Knowledge of Cybersecurity and Software Validation for Medical Devices:
  Familiarity with cybersecurity principles, software validation practices, and regulatory standards to address security and software reliability concerns.
• Hands-on Experience with Advanced Risk Management Tools (e.g., FMEA, FTA): Ability to apply advanced risk analysis techniques in compliance with ISO 14971 standards for risk management in medical devices.nt experience.

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. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be