Design Assurance Engineer

Integrated Resources, Inc ( IRI ) provided pay range

This range is provided by Integrated Resources, Inc ( IRI ). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$55.00 / hr - $60.00 / hr

Location : Marlborough, MA

Duration : 08+ Months

Shift & Timing : Regular Business Hours

Job Description :

• Provide design assurance support for new product development and on market medical devices.
• This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
• The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. Test method validation would be an element of assuring verification / validation is acceptable.
• Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed..
• Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
• Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis situation, including problem definition and impact.
• Assess change requests of product for impact to design, determine supporting information required for implementation of changes.

Qualifications & Skills :

Seniority level

Employment type

Job function

J-18808-Ljbffr