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17 days old

Sr Reliability Engineer

North Haven, CT 06473
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Sr Reliability Engineer


North Haven, Connecticut, United States

Requisition #:


Post Date:

Sep 02, 2020

**Careers that Change Lives**

You will be a key member of the Surgical Robotics Quality Organization as we develop and commercialize a Surgical Robotics Platform.

Impact Patient Outcomes. Do meaningful work, make a difference, and improve lives starting with your own.

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

**Surgical Robotics**

The Surgical Robotics business strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through the use of a minimally invasive surgical robotic solution.

**A Day in the Life**

Performs Quality Engineering functions in support of projects associated to product development/change including:design verification (Design for Six Sigma), reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a product team environment.Ensure that component and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed and validated.

Evaluation of component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations.

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

+ Overall responsibility for ensuring the adequacy of design quality for a Minimally Invasive Surgical System, including documentation and other supporting quality evidence.

+ Facilitating and managing Design and Process FMEAs/FMECAs in a research and development setting for Instrumentation and potentially other subsystems within the Minimally Invasive Surgical System.

+ Providing guidance and oversight of the plans and methods for subsystem verification.

+ Providing guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices.

+ Providing oversight and approval for Reliability Plans and ensure that they are properly executed throughout the development and qualification processes.

+ Participating in engineering Design Reviews

+ Participating in Defect / Issue Management and Change Control Boards, as appropriate.

+ Managing the Risk Management Process per ISO 14971 at a subsystem level.

+ Qualifying production components through Medtronics Production Part Approval Process (PPAP).

+ Developing Quality inspection procedures, including sampling plans, for both production level components and finished devices.

+ Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions.

+ Contributing to the development of Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.

+ Ensuring 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, RD, and Operations.

+ Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilize.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

**Nice to Have**


+ BS Degree in Engineering, Math or Physical Science


+ Minimum (7) seven years experience in design, manufacturing or quality engineering position (medical device experience preferred).

+ 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.)


+ Good communication skills, both written and oral and must be computer literate.

+ Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 14971, ISO 13485 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.

+ Preferred Skills/Qualifications:

+ ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)

+ Six Sigma Green belt or Black Belt certified

+ Geometric Dimension and Tolerance activities

+ Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 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. Lets 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)
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.


Posted: 2020-09-04 Expires: 2020-10-12
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Sr Reliability Engineer

North Haven, CT 06473

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