Careers that Change Lives Performs Quality Engineering functions in support of projects that require field service support and post market analysis. Support activities affecting the field service & repair of a medical device including design verification (regressing testing), on-going reliability engineering, and analysis of potential defects identified during field service activities.
Ensure that field replaceable components and assemblies have been properly assessed for potential failures. Ensure replacement components and finished devices are properly specified and tested and the associated field service processes are properly reviewed, analyzed and validated.
Overall responsibility for ensuring the adequacy of design quality for a field serviceable Minimally Invasive Surgical System, including documentation, post-market analysis and other supporting quality evidence.
Represent the Quality Engineering team on the Service & Support Core Team.
Generation of processes and procedures to comply with industry standards for field serviceable medical devices.
Facilitating and managing field service FMEAs in a research and development and post-market setting for multiple subsystems within the Minimally Invasive Surgical System.
Providing guidance and oversight of the plans and methods for Field Service verification activities.
Providing guidance on the principles of service and repair as they relate to commercialized product electromechanical medical devices.
Providing oversight and approval for regression testing and ensure that tests are properly executed.
Support the development of service manuals, technical bulletins, and other technical service documentation.
Support and be the team liaison to the PMV and After Market Services teams.
Participating in engineering Design Reviews.
Participating in Defect / Issue Management and Change Control Boards, as appropriate.
Managing the Risk Management Process per ISO 14971 as it pertains to field service and post market analysis.
Qualifying production components through Medtronic's Production Part Approval Process (PPAP).
Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions.
Ensuring FDA and ISO post-market analysis requirements are met and external AMS partners are complying to quality agreements
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 development and application of internal development procedures, including Design Control, to the service & support team, within the framework of regulatory requirements.
Interact and form constructive working relationships with all levels of leadership within the Service, Quality, Procurement, Marketing, R&D, and Operations organizations.
Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
Must Have: Minimum Requirements
Bachelors degree required
Minimum of 2 years of experience, or advanced degree with 0 years of experience
Nice to Have
Good communication skills, both written and oral and must be computer literate.
Knowledge of or experience in developing, manufacturing and servicing medical devices in conformance with Medical Device Quality System, ISO 13485, and Risk Management, ISO 14971, requirements.
Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE and the use of computer/software packages related to design, development and manufacturing.
ASQ Certified Quality Engineering (CQE)
Six Sigma Green belt or Black Belt certified
Five (5) years' experience in a design or quality engineering position (medical device experience preferred) where responsibilities included interaction with the field service team.
Three years of experience can be substituted for an Advanced degree in a related discipline. Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing. Statistical Quality Control/Statistical Process Control, Design of Experiments, Failure Mode and Effects Analysis. Experience in a regulated environment (FDA, ISO, etc.)
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)