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Quality Engineering Director, Surgical Post-Market

Medtronic
United Statesfull_timeVerifiedPosted 24 Nov 2024
💰 $280,800/yr

About the role

We anticipate the application window for this opening will close on - 2 Dec 2024


 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Quality Engineering Director, Surgical Post-Market Risk - reporting to the VP of Post Market Quality, Surgical.

Responsibilities may include the following and other duties may be assigned.

  • Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
  • May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
  • Oversees the investigation and evaluation of existing technologies.
  • Guides the conceptualization of new methodologies, materials, machines, processes or products.
  • Directs the development of new concepts from initial design to market release.
  • Manages feasibility studies of the design to determine if capable of functioning as intended.
  • Monitors documentation maintenance throughout all phases of research and development.
  • Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.

MINIMUM QUALIFICATIONS


Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 10 years of combined experience in quality, engineering or a related function with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of combined experience in quality, engineering or a related function with 7+ years of managerial experience.

SPECIALIZED SKILLS OR EXPERIENCE: 

  • Risk management experience in the medical device industry
  • Risk Management File lifecycle accountability
  • Experience in engaging with Regulatory Agencies and customers / clinicians
  • Statistical analysis tools and techniques
  • Significant breadth and depth in quality decision making, risk management, quality engineering, reliability engineering, and writing for compliance.

NICE TO HAVE

  • DRM Certification
  • Experience with complex capital, medical devices or software
  • Requires exceptional engineering knowledge and leadership capability within a business unit
  • Reliability Engineering Test experience
  • Typically has deep domain expertise and applies extensive engineering and industry expertise

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 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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$187,200.00 - $280,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.

The

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Company

Medtronic

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