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Senior Mechanical Design Engineer

3 months ago

Fort Lauderdale, United States PDDN INC. Full time
Job DescriptionJob DescriptionCompany Description

PDDN is a provider of end-to-end software solutions and IT consulting Services and software development Company. is headquartered in Fremont, California with clients across the Silicon Valley and other Information technology Hubs in different states. With integrated solutions, software development, technical services, training and staffing support, we help customers achieve their technology goals allowing them to focus on their business.

 

Job Description

Role: Senior Mechanical Design Engineer
Location: Fort Lauderdale, FL %100 onsite role
Interview: Phone/Skype
Emp Type: Contract
 

Job Description:
Reporting to the Development Manager, the Senior Design Engineer carries out development activities for medical devices, including design, prototyping, technical analyses, and testing.
The Senior Design Engineer collaborates closely with cross functional project teams to ensure that designs meet user needs, quality requirements, and consider manufacturability.
The Senior Design Engineer will communicate directly with customers and manufacturing teams and will be required to travel ?10% of the time.
The Senior Design Engineer will also support regulatory filings for combination products.

Skills and Qualification
Biomedical Engineering, SolidWorks, mechanical design, statistical analysis, Finite Element Analysis, FEMA risk management
4-7 years of experience
BS Mechanical Engineering/BS Biomedical Engineering
Proficient at mechanical design (SolidWorks preferred)
Proficient at technical analyses including statistical analysis and tolerance analysis
Proficient at performing Finite Element Analysis
Knowledge of manufacturing processes including injection molding
Knowledge of risk management processes including FMEA
Knowledge of regulations and standards including: 21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971
Demonstrates good judgment as well as cultural, social, and environmental awareness"

Main Responsibilities
Execute design and development of drug delivery devices following design controls
Plan testing for characterization, design feasibility, and Design Verification
Perform technical analyses including statistical analysis and tolerance analysis
Lead root cause investigations
Support commercialization and scale-up efforts
In a non-supervisory capacity, provide guidance and coaching to team

Additional Information

All your information will be kept confidential according to EEO guidelines.