Job Listing Description

THIS JOB IS NO LONGER AVAILABLE. THIS IS ARCHIVAL INFORMATION.
Manufacturing Engineer

Description:
Job Summary: Position is responsible for a variety of project-based Functions, all of which are related to the Manufacturing, Compliance And Design of Medical Device Products.

Required Skills: Manufacturing process per FDA requirements for medical devices

Essential Functions:

Project Engineering role in product commercialization, coordinating component manufacturing and assembly process Development.
Support validation of all manufacturing Processes per FDA requirements for medical device development
Implement production control methods to monitor process output And establish critical supplier metrics.
Define and coordinate the design and development of manufacturing fixtures and test equipment, including MSA and Gage R & R.
Perform or direct DOE, correlation studies and apply statistical analysis for process and product improvement.
Define runoff requirements, and conduct capability, stability, first article inspection and other statistical analysis as required.
Conduct D/PFMEA to evaluate potential failures and implement mitigation.
Insure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Process.
Create and maintain product assembly instructions
Create and maintain BOM and Routings.
Must be action-oriented with demonstrated customer focus and problem solving skills and enjoy working in a dynamic work environment with a focus on technical excellence, customer responsiveness and creative thinking.
Able to adapt to shifting priorities, handle a rapid pace environment, and to resolve problems/conflicts.
Skills/Qualifications/Competencies:

Must have experience in manufacturing and assembly process development and validation (IQ, OB,PQ andPPQ).
Mechanical or electro-mechanical manufacturing experience in the medical device industry.
Experience with sterilization and sterilization validation, experience with packaging development and packaging validation, experience with cannula/needle manufacturing and handling, experience with plastic injection molding of medical products, formal Six Signma or lean training and working experience.
Bachelor's Degree in Mechanical Engineering or other relevant Engineering discipline. 8 - 10 years of relevant work experience may be considered in lieu of a Bachelor's Degree.
Understanding and experience with product design phases leading to commercialization including the use of tools such as DFMEA, PFMEA, and Risk Analysis.
Excellent project management skills. Microsoft Project or Project Management Tools required.
Superior verbal and written communication skills.
Root Cause Analysis (DOE, Regression, KT, BD, Hypothesis testing, etc.)

Job Number: WW050517MZ
Job Location: Mesa, AZ
Rate: DOE
Per Diem: YES
Overtime: YES
Duration: 6-12 MONTHS
Start Date: 06.01.17
Input Date: 11/14/2020

Firm Name: ENEA SOFTWARE AND SERVICES
Attention: Walter Walonoski
Address: 2555 E CAMELBACK RD STE 280
City, State: PHOENIX, AZ 85016
Phone: 480/753-9200
Fax Phone: 480/753-6400
Website: www.enea.com/services/expertise

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