Validation Engineer – Medical Devices (Design Controls)

360 IT Professionals; City of Rochester (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

A technology solutions company located in Rochester, NY, is looking for a Validation Engineer with a minimum of 5 years of experience in Medical Device quality system management. Ideal candidates will hold a BA/BS in relevant fields and possess strong data analysis skills. Responsibilities include executing failure investigations, ensuring compliance with quality systems, and collaborating with multiple departments to optimize product performance. This role offers a 12-month duration with the possibility of extending based on performance.

Qualifications

• Minimum of 5 years of related experience in Medical Device quality system management.
• ASQ certification a plus.
• Must work independently and ensure compliance to Design Controls.

Responsibilities

• Ensure effective implementation of risk management requirements.
• Provide technical input as appropriate.
• Execute Failure Investigations and corrections of design-related issues.

Skills

Medical Device quality system management

Computer skills/data analysis (Word, Excel, PowerPoint, Minitab, Visio, MS Project)

Effective oral & written communication

Six Sigma/Process Excellence

Education

BA/BS in Life Sciences, Engineering, or Physical Science

MA/MS in Life Sciences, Engineering, or Physical Science

Job description

A technology solutions company located in Rochester, NY, is looking for a Validation Engineer with a minimum of 5 years of experience in Medical Device quality system management. Ideal candidates will hold a BA/BS in relevant fields and possess strong data analysis skills. Responsibilities include executing failure investigations, ensuring compliance with quality systems, and collaborating with multiple departments to optimize product performance. This role offers a 12-month duration with the possibility of extending based on performance.