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Engineer III

Irvine, CA, US • Posted 30+ days ago • Updated 38 minutes ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Product Development
Test Methods
Mechanical Engineering
Medical Devices
Regulatory Compliance
Testing
Management
Test Equipment
IQ
OQ
PQ
Standard Operating Procedure
Lean Six Sigma
5S
Communication
Presentations
GD&T
SolidWorks
ISO 13485
Risk Management
Design Controls
Manufacturing
Documentation
Development Testing
Minitab
JMP
Six Sigma
Statistics
Design Of Experiments

Summary

Responsibilities:

Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals.
Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
Define, develop, and validate/transfer test methods.
Create verification plans, protocols, records, and reports. Support investigations and issue resolutions.

Requirements:

degree in an engineering field (mechanical, materials, packaging, bioengineering): BS or equivalent education with 5-10 years of experience; MS or equivalent education with 3+ years of experience.
Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
Significant background in engineering testing and analysis including:
Direct experience of test equipment validation (IQ, OQ, PQ) is required.
Must be able to demonstrate relevant experience in statistical analysis.
Documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports.
Proficiency in MS Office, MS Project, Solidworks, Minitab or JMP.
Lean Six Sigma, 5S experience desired.
Good communication skills, both written and oral. Ability to prepare technical reports and presentations.

What are the top 3-5 skills, experience or education required for this position:

Experience creating engineering drawings, proficiency with GD&T dimensioning, CAD design (SolidWorks) and tolerance stack analysis.
Experience with ISO 13485 and 14971 quality system and risk management principles.
Experience with design control, DHF documentation, and good manufacturing/documentation practices.
Experience with fixture design, fixture development, test method validation.
Experience with statistical software (Minitab or JMP), Six Sigma statistics and Design of Experiments.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 24115293b9bc68856d827e38a99f0f49
Posted 30+ days ago

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