Director of Quality Engineering

Medtronic Inc.
North Haven
Oct 05, 2017
Oct 19, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Director of Quality Engineering

Careers that Change Lives

The Director of Quality Engineering is responsible for leading the new product development Quality Engineers from concept through market introduction on the Robotic Surgical Platform. The position will be integral in the delivery of Quality Design deliverables and verifying the Quality Management System requirements have been met while meeting time-to-market and technology objectives. This position works closely with the product development, operations, supplier management, and project management teams to ensure compliance to the Quality Manual, Design Control, Supplier Management and other appropriate procedures have been met.

A Day in the Life

You will lead Quality Engineering functions involved in aspects of design verification (Design for Six Sigma), reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a project team environment. Evaluate component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations. Ensures that components and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed, and validated. Performs failure analysis to prevent or correct component and product failures.

Support integration of both mechanical and electronic technologies into surgical devices during product design and launch phases.

The Director of Quality Engineering a) supports the integration of mechanical and electronic technologies in new product development for surgical devices during product design and launch phases; b) oversees the Quality representative on cross-functional new product development teams; c) is assigned leadership responsibility for multiple projects or subprojects related to new product development or process improvement; d) is skilled in advanced problems solving and developing cross-functional solutions to complex business or regulatory problems; e) possess advanced knowledge of quality systems and is experienced working with R&D teams and suppliers in driving quality improvements.

In this role, you will:

* Apply six-sigma, LEAN, and project management principles to advance NPD objectives

* Provide design input and recommends alternatives

* Implement and Execute tactical elements of department's strategic plans

* Assist in designing and improving quality systems, processes and metrics

* Perform engineering measurements and statistical analysis

* Contribute to engineering schedules and plans

* Write / Review engineering test protocols, reports, Risk Management tools including FMEA's (Design Process), CTQ's, Design Verification and Validation, Control Plans, DOE, MSA, Software development, Service and Process Validation plans.

* Collaborate and work effectively across functional areas (R&D, Purchasing, PMO, Mfg., etc.)

* Prepare monthly progress reports, internal/external formal presentations, and written reports

* Demonstrate knowledge and understanding of Good Manufacturing Practices and all applicable standards.

* Assure compliance with company Standard Operating Procedures and policies

* Participate in team decision making

* Stay informed about applicable new rules, regulations, and standards

* Maintains a clean, safe, and orderly work area.

* Follow all safety procedures and SOP's

* Hire, mentor and develop Quality Engineers and educates QA/operations staff on quality principles and regulatory requirements

* Stop the manufacture and/or distribution of medical devices should it be determined that the safety, quality, identify of the product or process has been compromised.

Must Have: Minimum Requirements

* Bachelor's degree, or equivalent, in Mechanical or Electrical Engineering, or related field.

* Minimum of 10 years experience in medical device manufacturing with an emphasis on quality, quality management systems and new product introduction

* Minimum of 7 years increasing managerial responsibilities

* Knowledge of New Product Development processes

* Knowledge of engineering practices, test protocols, and documentation

* Knowledge of purchasing, supplier management, and supplier quality processes

* Skilled in problem solving and process improvement

* Skilled leading cross-functional teams or working individual

* Skills in personal computer spreadsheet, word processor, and engineering tools

* Ability to carry out engineering calculations and analysis

* Ability to write engineering documents, test protocols, laboratory notebook entries and reports

* Ability to perform component engineering design and changes

* Ability to operate light machine tools and laboratory instruments

* Ability to interpret displayed results on laboratory instruments.

Nice to Have

* Master's degree in Mechanical or Electrical Engineering, or related field.

* Experience with electro-mechanical medical devices a plus

* Experience with software driven medical devices a plus


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. 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.


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.


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