Engineer III

Branchburg, NJ, US • Posted 7 hours ago • Updated 7 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

PDS
Research and Development
IT Management
Development Testing
Test Execution
Management
Prototyping
Statistics
Minitab
JMP
Regulatory Compliance
GxP
Product Development
Product Requirements
Design Controls
Verification And Validation
Strategy Development
Testing
Data Analysis
Medical Devices

Summary

Location: Branchburg, NJ (Hybrid)

Responsibilities:

Serve on project technical team, consisting of cross-functional resources including but not limited to R&D, PDS&T, Quality, Biocompatibility, and Regulatory.
Partner with R&D to identify user and technical product requirements for a medical device product.
With Technical Lead, develop Design Verification & Validation strategy.
Support Design Verification (planning, fixture development, method development, test method validation, protocol development, and test execution).
Drive the creation and execution of protocols and reports.
Manage Design History File content.
Participate in prototyping activities to transform concepts into functional devices.
Perform laboratory testing, including independently designed experiments to further project goals.
Conduct statistical analyses using software such as Minitab or JMP to evaluate data and support design decisions.
Ensure compliance with company and industry standards regarding safety, quality, and regulatory policies (including GxP).

Qualifications:

Bachelor's Degree or equivalent education with 5 or more years of experience or Master's degree or equivalent education with 3 or more years of experience.
Experience with new product development, including defining user and technical product requirements.
Experience with Design controls, including Design Verification & Validation strategy development and execution.
Experience with laboratory testing as well as subsequent data analysis using statistical methods.
Experience with medical device regulatory submissions.
Experience with biological-based products preferred.

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: f5c44d5dce1ba5dfef29797c0885f8d5
Posted 7 hours ago

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