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Hardware Design Assurance Engineer II

19000F9O Requisition #
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Careers That Change Lives


Medtronic is currently seeking a Hardware Design Assurance Engineer II.


Your dedication is important to our customers and, most importantly, to their patients. 

In this role, you will be an integral team member for the development of new Medical devices at Medtronic’s growing Enabling Technologies division. You will be responsible for leading the product quality and reliability assessment. To be successful in this role you will be well rounded with a strong statistical background and recent hands on experience with quality and reliability tools and their application. Projects will include early development through transition to manufacturing.



Do meaningful work, make a difference, and improve lives - starting with your own.  


The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.



A Day in the Life


• Integral member of design team required to participate in activities related to the quality and reliability of the design. 

• Participate in design trade-off studies. 

• Risk assessment activities. 

• Collaborate with core team members to execute supplier integration.  

• Work closely with Development Engineering to assure appropriate requirement definitions are established. 

• Work with development engineering and manufacturing engineering to translate design requirements to manufacturing requirements. 

• Definition of clinically relevant test methods for development and manufacturing testing. 

• Actively participate in the product development cycle to ensure quality issues are addressed and resolved prior to release.

• Complete reviews and audits of Design History File (DHF) documentation. 

• Assist in the development and implementation of methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Establish incoming inspection requirements and revise as necessary. 

• Be a key contributor in problem solving efforts to identify and resolve challenging quality issues to ensure production of safe and effective medical devices.

• Perform process capability studies.

• Implementation of changes and upgrades to systems, procedures, and processes to improve product quality.

• Provide well-written reports and supporting documentation. 

• Implement corrective and preventive actions to improve quality.

• Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures. 

• Promote continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen. 


You may also be responsible for:

  • Developing, modifying, applying and maintaining quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborating with engineering and manufacturing functions to ensure quality standards are in place.
  • Collaborating with mechanical engineering and manufacturing functions to ensure supplier is capable of producing and inspecting components.
  • Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designing or specifying inspection and testing mechanisms and equipment; conducting quality assurance tests; and performing statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensuring that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.


Must Haves Minimum Requirements


B.S./B.A. in Engineering or similar related field and 2+ years experience in a Reliability or Quality role in a regulated environment or an advanced degree



Nice to Have


  • Mechanical Design Experience

  • Understanding of metal and injection molding manufacturing processes

  • Understanding of FDA standards.

  • Medical device experience. 

  • Design for Manufacturability 

  • Demonstrated use of Statistical Analysis tools. 

  • Experienced in Planning, executing and reporting Design Verification. 

  • ISO standards knowledge

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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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 independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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