Sr Design Quality Engineer
Careers That Change Lives
In this exciting role as a Senior Design Quality Engineer you will have responsibility for contributing to the design and development of Instrumentation that will be utilized to deliver targeted therapy in conjunction with Medtronic’s surgical robotic system. This role will be responsible for guiding and helping developing Design Quality Engineers across the organization.
MITG
The Surgical Robotics business strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical robotic solutions.
SURGICAL ROBOTICS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
Responsibilities may include the following and other duties may be assigned.
- Support the design quality for a capital hardware subsystem for the Minimally Invasive Surgical System, including documentation and other supporting quality evidence.
- Facilitate and manage Design and Process FMEAs/FMECAs in a research and development setting for the Wristed and Advanced Instrumentation and potentially other subsystems within the Minimally Invasive Surgical System.
- Provide guidance and oversight of the plans and methods for subsystem verification.
- Provide direction on correct GD&T leading to identification of Critical to Quality elements.
- Provide oversight and approval for Reliability Plans, Protocols and Fixtures and ensure that they are properly executed throughout the development and qualification processes.
- Participate in engineering Design Reviews.
- Participate in Defect / Issue Management and Change Control Boards, as appropriate.
- Collaborate and Manage the Risk Management Process per ISO 14971
- Qualify production components through Surgical Robotic’s Production Part Approval Process (PPAP)
- Develop Quality inspection procedures, including sampling plans, for both production level components and finished devices.
- Initiate corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions.
- Contribute to the development of Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.
- Ensure all FDA and ISO validation requirements are met and for the review and approval of all validation protocols (IQ, OQ, PQ and MSA).
- Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
- Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative products.
- Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.
- Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering, Quality and/or regulated industry or Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering, Quality and/or regulated industry.
- Master’s Degree in Engineering.
- Experience with New Product Development in the medical device industry.
- Green or Black Belt Six Sigma Certification (DFSS or DMAIC)
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 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 Day in the Life 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.
Travel <= 10% to domestic and/or international supply chain
