Hardware Design Assurance Engineer II

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.