R&D Engineer (Design Verification & Validation, Data Analysis Exp is Required) - Urgent Need

millenniumsoft•Tempe, AZ

14d

About The Position

Assist with the remediation process of existing products in efforts to bring the product lines in compliance with the EU MDR regulations for the Product Engineering Surgical franchise. Provide solid technical skill and engineering support for design and development activities for existing products. Participates and/or leads cross-functional teams. Support current products in terms of quality, manufacturing, supply continuity and cost improvement. Participate in executing technical and/or cross-functional project work. Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. Write detailed technical reports based on design verification analysis/testing for design changes and product design activities. Prepares and presents oral and written project updates and technical discussions to relevant stakeholders. Creates, executes, and tracks project plans in MS Project to completion while maintaining the overall project budget. Ensure compliance with client quality policies, procedures, and practices as well as with all local, state, federal and client safety regulations, policies and procedures. BS degree in engineering is required (Mechanical or Biomedical Engineering preferred) with a minimum of 4 years of engineering experience is required, preferably in medical devices or master’s degree (Mechanical or Biomedical Engineering preferred) with a minimum of three years of engineering experience. Demonstrated ability to utilize MS Project, statistical tools, and computer analysis.

Requirements

Design verification/validation protocol and report writing (including statistical data analysis using statistical analysis software)
Develop and coordinate test method and design validation/verification activities
Project management experience (lead projects preferred)
Bachelor of Science in Engineering (Mechanical or Bioengineering preferred) with minimum 3 – 4 years of professional experience or Master of Science (Mechanical or Bioengineering preferred) with minimum 2 years professional experience
BS degree in engineering is required (Mechanical or Biomedical Engineering preferred) with a minimum of 4 years of engineering experience is required, preferably in medical devices or master’s degree (Mechanical or Biomedical Engineering preferred) with a minimum of three years of engineering experience.
Demonstrated ability to utilize MS Project, statistical tools, and computer analysis.

Responsibilities

Assist with the remediation process of existing products in efforts to bring the product lines in compliance with the EU MDR regulations for the Product Engineering Surgical franchise.
Provide solid technical skill and engineering support for design and development activities for existing products.
Participates and/or leads cross-functional teams.
Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
Participate in executing technical and/or cross-functional project work.
Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis.
Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.
Prepares and presents oral and written project updates and technical discussions to relevant stakeholders.
Creates, executes, and tracks project plans in MS Project to completion while maintaining the overall project budget.
Ensure compliance with client quality policies, procedures, and practices as well as with all local, state, federal and client safety regulations, policies and procedures.