A Day in the Life
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.
Medtronic
At Medtronic, we value what makes you unique.
Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose
The Design Assurance Engineer (DAE) plays a critical role in ensuring the safety, efficacy, and quality of products during the design and development phases.
This position is essential for delivering high-quality, compliant, and effective products to the market while adhering to applicable industry and regulatory standards.
A Day in The Life Of:
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 that 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
Specific Skillsets:
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.
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.
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.
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