ENSURING SUCCESSFUL DEVELOPMENT OF NEW

PRODUCTS

When I am hired for the role of the Design Assurance Engineer, I serve on new product development teams (core teams), contributing to ensuring product quality, reliability, manufacturability, serviceability, regulatory compliance and fulfillment of customer expectations. 

Here are the highlights of what I can do for your Design Controls:

• Create and maintain Design History Files (DHF).

• Create and maintain Risk Management Files (RMF).

• Prepare Risk Management plans, protocols and reports.

• Facilitate and document Design FMEAs and Use FMEAs.

• Prepare Hazard Analysis Reports.

• Perform Test Methods Validations (TMV).

• Perform Gage R&R studies.

• Perform gap analysis.

• Support Design Verification and Validation.

• Support Design Reviews.

• Support IEC 60601 compliance testing and agency submission.

• Support PMA and 501K submissions.

• Support design transfer to manufacturing.

• Work with suppliers on improving their products and processes.

• Prepare, review, revise, and edit documentation. 

• Prepare and process Engineering Change Orders (ECOs).

Click here to read about a tested approach for improving design controls that might work for you as well.

To discuss how I can help you with Design Controls, contact me here.