2015-12-05

## Description

Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $*8b company with more than 85K employees in more than 160 countries.

**_SUMMARY OF POSITION_**

* In consultation with the Manager (Reliability Assurance)/ Principal Engineer Reliability Assurance, establishes the Reliability Engineering Department which would have the capability in personnel and resources to validate reliability and quality of new products under development in addition to sustaining support for the existing products at various global business units (GBUs) of Covidien.

* Would be responsible for assisting the Manager/ Principal Engineer in reliability program management, design quality management, safety risk management, reliability & quality issues for new product/process introduction and improvement for ongoing and developmental projects, production trouble shooting with respect to reliability and quality design issues and individual measurement and analysis.

* The overall job of the Senior Engineer Reliability & Testing is one of contributing positively in creation and innovation, which would lead to the development and introduction of new and tailored products.

**_ _**

**_ESSENTIAL DUTIES AND RESPONSIBILITIES:_**

The Senior Reliability & Test Engineer would be responsible for:

* Assisting the Manager/ Principal Engineer in Reliability Program and Safety Risk Management of medical devices

* Determines environmental test requirements for the products and specifies minimum number of samples to obtain statistically valid data.

* Review subcontractors' proposals for reliability program and submits evaluation for decision.

* Observe the conduct of tests at supplier, plant, or field locations to evaluate reliability factors, such as numbers and causes of unit failures.

* Monitor failure data generated by customer using product to ascertain potential requirement for product improvement

* Proactively design in reliability and demonstrate that products/systems perform as expected in all use environments throughout their intended life (minimize the need to iteratively redesign for reliability)

* Identify product/system use conditions and quantify how they impact performance - Quantify how performance changes as a result of variability (e.g., manufacturing process, component/material, interfaces, etc.)

* Perform design reliability verification, reliability modeling & identify product reliability stressors**__**

* Functioning as a member of cross functional teams by providing reliability, quality & testing technical expertise for projects or subprojects

* Preparing time and cost estimates for projects from R & Q infrastructure/ test equipment issues as applicable

* Providing strong technical contributions to quality improvement of product/process for development and tailored products

* Administers the safety risk management process for new product development.

* Administers the reliability program for new product development including RGA under guidance of team leader.

* Provides technical leadership to teams of engineers and technicians in the pursuit of new technology.

* Provides consulting and troubleshooting on technical problems that arise in product and process development.

* Provides mentoring and developmental leadership to direct reports

* Maintains appropriate communication channels with direct reports

* Develops creative and innovative approaches to new processes and products.

* Performs engineering measurements and analysis.

* Records work in design history files.

* Contributes to engineering schedules and plans.

* Instructs engineers and technical support staff on engineering test and build requirements.

* Prepares cost and time estimates for engineering schedules as applicable.

* Provides written reports, protocols, and personnel assessments as necessary.

* Provides cost and activity accounting period reports as necessary.

* Executes tactical implementation of strategic plans.

* Assures compliance with company Standard Operating Procedures and policies.

* Participates in team decision making.

* Develops team problem solving and communication skills

* Demonstrates skill in the use and care of all tools and equipment.

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

* Stays informed about applicable new rules, regulations, and standards.

* Writes engineering test protocols for testing of component parts and integrated systems.

* Prepares progress reports on projects as required.

* Prepares oral presentations for various company meetings.

* Develops and writes reliability & quality specifications for components/systems, product, processes, and packaging/labeling.

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

* Follows all safety procedures.

Travel in India and abroad to various global business units and engineering support partners related to above mentioned activities/ training.

## Qualifications

**_PRINCIPAL WORKING RELATIONSHIPS:_**

* Works with other engineering personnel to create and develop engineering prototypes of new products/processes.

* Works with RA, QA and Documentation departments to establish proper regulatory and quality documentation procedures.

* Works with Manufacturing on production problems and changes as necessary.

* Works with R&D;, Marketing and cross-functional teams to improve the reliability & quality of new products under development.

* Works as a team member, when required, in the development of engineering designs and tests.

* Supplies Purchasing Department with specifications regarding parts to be purchased and OEM products/processes.

* Works with Safety, Health and Wellness, affected employees, and other necessary resources to ensure the highest feasible level of safety and hazard control.

* Works directly with finish goods suppliers in all aspects of product/process development, release, and sustaining activities.

**_KNOWLEDGE, SKILL, AND ABILITY_****:**

* Knowledge of Standards Applicable to Medical Device Safety Risk Management (ISO 14971, ISO 62304, IEC 60601-1, etc)

* Knowledge of Reliability Engineering Principles and Reliability standards

* Knowledge of electronics component reliability specifications & screening methods.

* Must have hands-on ability with software tools such as Weibull+​+​; LambdaPredict, ALTA; XFRACAS; XFMEA; BlockSim, DOE++ or other equivalent reliability software, Minitab or other statistical tools.

* Knowledge of Change Order System.

* Knowledge of engineering documentation.

* Knowledge of engineering test protocols.

* Knowledge of Design Control System (DCS).

* Knowledge of engineering laboratory procedures.

* Knowledge of Purchasing Department procedures.

* Knowledge of company reporting structure.

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

* Ability to carry out engineering calculations, analysis and problem solving.

* 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 stay on the leading edge of applicable technology and techniques.

* Ability to interpret displayed results on laboratory instruments.

* Ability to make oral presentations at company meetings.

* Effective oral and written communication skills.

**_EDUCATION_****:**

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

* Preferred: ****

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

* ASQ Certification CRE****

**_EXPERIENCE_****:**

* Required: 8-10 years’ experience in engineering practice.

* Preferred: Minimum Four (4) of the total experience should be in quality/reliability engineering practice in a regulated environment (FDA 21 CFR, ISO 13485, ISO 9000, FAA, Automotive, etc.)

*Primary Location:* Asia-India-Andhra Pradesh-Hyderabad

*Job:* R&D;

*Organization:* India

*Job Posting:* Dec 4, 2015, 12:17:36 AM

*Req ID:* 150004Q7

Show more