Senior Reliability Engineer - CHICAGO

Company: Intellectt INC
Your Application: You have not applied yet
Location: CHICAGO, USA
JOB DESCRIPTION

Role: Senior Reliability Engineer
Location: Abbott Park, Illinois
Duration: 12 Months on w2

Shift Time: 8:10AM-5:00PM

Job Description

Contribute to resolving significant technical issues and to the development of company and program objectives. Works independently or in a lead role on the design and development of test fixtures and Python scripts, for product testing. Works independently on identifying and developing alternate designs to increase system/product reliability.

Exercises independent judgment in identifying, recommending and guiding significant complex new design improvements to meet reliability goals. May lead technical teams in the accomplishment of electrical or mechanical engineering activities. Develops networks involving cross-functional/cross departmental groups as well as communication to senior management.

Main Responsibilities Legacy System

Contribute to resolving significant technical issues and to the development of company objectives. Works independently or in
a lead role on the design and development of products. Works independently on identifying and developing new technologies
for implementation into new products. Exercises independent judgment in identifying, recommending and implementing
significant and/or complex new design improvements to meet new product development and regulatory requirements. May
lead technical teams in the accomplishment of engineering activities. Develops networks involving
cross functional/cross departmental groups as well as communication to senior management.


MAIN RESPONSIBILITIES


Responsible for the development of technical project plans and schedules covering all engineering activities, meeting all
design control and product development SOP requirements.
Works with development teams, developing significant design specifications, FMEAs, DOEs, verification and validation protocols.
Participates in technical design reviews of products and design requirements document.
Writing, submittal, and approval of Engineering Changes, as required.
May review and approve ECs
. Communicates effectively and participates on cross functional development teams.
Responsible for utilizing the quality system.
Ensures that products meet all applicable standards.
Responsible for compliance with applicable Corporate and Divisional Policies.
Development and execution of new medical devices, processes, equipment, materials, verification and validation
Follow approved Design Control procedures for development in accordance with FDA guidelines.
Designs test fixtures for durability testing.
Designs and develops test scripts to run subsystem life tests.
Provides direction to technicians conducting reliability tests and durability tests.
Runs preliminary reliability tests until reliability technicians are hired and trained.
Develops test methods and instructions for reliability testing and durability testing.
Reviews manufacturing instructions for reliability impact.
Works with external suppliers and internal engineers to ensure instrument designs are following manufacturers recommended applications guidance.
Reviews preventive maintenance for reliability and durability impact.
Participates in Sub-system Design Reviews, and Cross-functional team meetings, providing reliability input.

Additional Main Responsibilities from Legacy System

Specify, optimize, verify and validate new products, in accordance with applicable medical regulatory standards.
Responsible for the development of technical project plans covering engineering activities, meeting design control and product development SOP requirements.
Works in the development of significant design specifications, FMEAs, DOEs, verification and validation protocols.
Works in the creation of schedules and budgets.
Communicates effectively and participates on cross functional development teams.
Participates in technical design reviews of products and design requirements documents.
Writing, submittal, and approval of Engineering Changes, as required.
May review and approve ECs.
Act as independent reviewer on programs which are not directly involved.
Responsible for utilizing and maintaining the effectiveness of the quality system.
Ensures that products meet all applicable standards.


Responsible for compliance with applicable Corporate and Divisional Policies.

Accountability/Scope/Budget from Legacy System

Development and execution of new medical devices, processes, equipment, materials, verification and validation Implement
approved Design Control procedures for development in accordance with FDA guidelines.

Education Level

Preferably In Electrical Engineering or equivalent. Mechanical engineers with significant experience in Python scripting will also be considered.
engineering or scientific discipline. (an equivalent combination of education and work)
experience

Experience/Background

Minimum 8 years Relevant experience. Some experience in technical
Leadership is desirable.
Good knowledge of general engineering principles.
Solid knowledge of regulations for medical device development, (ISO15197, ISO134851,
ISO13485, FDA). Strong technical experience in electrical engineering discipline with
Excellent written and verbal communication skills are essential.
Extensive understanding of processes and materials used in the development and
manufacturing of medical devices.
Experience in all of the following: -Writing Python scripts to control electro-mechanical instrumentation or equipment. Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis, six-sigma analysis. Working in an R&D development environment with an emphasis on medical device product
development. -Writing product test protocols and reports. -Support
test equipment/method validation desired -Working on a
development team with an emphasis on minimizing time to market. -Design for
manufacture of highly reliable, high volume electro-mechanical products.
Solid understanding of GxP, ISO and medical device regulations, particularly with respect
to the development of new products in a regulated environment.
Experience working in cross-functional team environments is required.
Licenses and Certifications


Additional Qualifications from Legacy System

Bachelor's degree in Electrical Engineering or equivalent engineering or scientific discipline
Masters degree is a plus.
8 yrs relevant experience and a BS degree or 5 yrs relevant experience and a MS degree.
Some experience in technical leadership is desirable. Good knowledge of general engineering principles.
Solid knowledge of regulations for medical device development, (ISO15197, ISO134851, ISO13485, FDA). Strong technical experience in electrical engineering discipline with excellent written and verbal communication skills is essential.
Extensive understanding of processes and materials used in the development and manufacturing of medical devices.

Experience in all of the following:


Performing complex engineering calculations and relating results to controlled tests, including statistical analysis and tolerance
analysis.
Working in a development environment with an emphasis on medical device product development.
Writing product Test protocols and reports.
Support equipment/facility/process commissioning and validation desired
Working on a development team with an emphasis on minimizing time to market. Design for manufacture of highly reliable, high volume electro-mechanical products.
Solid understanding of GxP, ISO and medical device regulations, particularly with respect to the development of new products in a regulated environment.
Experience working in cross-functional team environments is required.


Thanks & Regards

shankar

A: Intellectt Inc | 517 Route 1 South, Suite 1115 | Iselin, NJ - 08830
E: shankar@intellectt.com

P: 732-200-2105 X:186

In my absence, you may contact Eswar | Recruitment Lead | 732-654-7019 | Eswar@intellectt.com


Employment type: W-2


JOB TYPE
Work Day: Full Time
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: No experience



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