What are the responsibilities and job description for the Engineer III position at Katalyst Healthcares and Lifesciences?

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.

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Engineer III