Principal Robotics Post-Market Quality Engineer

Engineering             ·            North Haven, Connecticut, United States            ·          Full time

Locations:  North Haven, Connecticut, United States

Job ID: 230006SC

Job Description

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.  Join us for a career in Quality Engineering that changes lives.

Careers that Change Lives

A Day in the Life

Position Responsibilities May Include The Following And Other Duties May Be Assigned:

• Coordinates and conducts technical product investigations alongside cross-functional peers
• Represents the Quality Engineering organization on Defect / Issue Management & Change Control Bboards.
• Provide support to and advise the Customer Quality Experience Management team on post-market product analysis trends.
• Lead the bi-monthly Complaint Monitoring Signal Threshold Analysis and deliver monitoring reports as applicable.
• Construct and deliver the Robotic Surgical Technologies weekly field performance summary.
• 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 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Specialized Skills Or Experience: 

• Black Belt in DRM (Design for Reliability & Manufacturability) or Lean Six Sigma
• Expertise in Leading Cross Functional teams through Investigations and Identification of Root Cause(s)
• Comfortable operating in an Operating Room or Clinical Environment (will need this person be able to enter an OR and observe cases)
• Working experience in Statistical Quality Control/Statistical Process Control (Minitab preferred), Design of Experiments, Failure Modes and Effects Analysis

Nice To Have

• 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

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)

Min Salary: 112,800
Max Salary: 169,200
Travel: Yes, < 25 % of the Time

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