Join to apply for the Principal Design Assurance Engineer role at Medtronic.
At Medtronic you can begin a lifelong 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.
Responsibilities
* Quality Planning: Collaborate with cross‑functional teams to establish and implement quality plans, ensuring alignment with regulatory standards (e.g., FDA, ISO).
* Risk Management: Support the review of risk management documentation, ensuring design inputs address reliability, software, and supplier/process requirements. Update and maintain risk documentation, including FTA, DFMEA, HA, and SHA.
* Design Verification & Validation: Lead or support verification and validation activities to confirm that products meet design inputs and user needs through rigorous testing and validation.
* Process Oversight: Ensure adherence to design control processes, including traceability of requirements, design reviews, and design history file (DHF) documentation.
* Regulatory Compliance: Partner with regulatory teams to ensure designs meet global regulatory and quality standards.
* Problem Solving: Investigate and resolve design‑related quality issues in collaboration with engineering, manufacturing, and quality teams.
* Continuous Improvement: Provide feedback and recommendations to improve design processes, product reliability, and overall quality.
* Documentation: Maintain and review quality documentation to ensure completeness and accuracy for regulatory submissions.
Key Skills & Experience
* The role requires skillsets similar to BVNA responsibilities.
* Focus on candidates with a strong background in quality assurance, risk management, and regulatory compliance.
* Candidates should have the ability to challenge the status quo and drive continuous improvement.
Desired Skills And Strengths
* Technical Expertise: Demonstrated ability to review and approve technical specifications.
* Assertiveness: Willingness to speak up and challenge processes when necessary, with a focus on driving improvements.
* Adaptability: Capacity to learn new products, technologies, and processes quickly.
* Continuous Learning: Demonstrated commitment to professional growth and staying current with evolving industry standards.
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 and 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. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
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.
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