R&D Engineer (Must Have Design Verification/Validation, Test Method, Projext Mgmt Exp)

MillenniumSoft Inc; Tempe (AZ); On-site; USD 28,000 - 34,000; Full time

Job summary

MillenniumSoft Inc. is seeking an R&D Engineer in Tempe, AZ, contract role. Must-have experience includes design verification/validation, test method development, and project management. 12-month assignment, 40 hours/week, first shift, W-2 contract for US citizens or GC holders.

The role focuses on remediation for EU MDR compliance, design and development support for existing products, and cross-functional team leadership to ensure quality, manufacturing, supply continuity and cost improvements.

Qualifications

• Design verification/validation protocol and report writing, including statistical data analysis.
• Develop and coordinate test method and design validation/verification activities.
• Project management experience; lead projects preferred.

Responsibilities

• Assist remediation to bring products into compliance with EU MDR for Surgical franchise.
• Provide engineering support for design and development activities of existing products.
• Lead or participate in cross-functional teams to support quality, manufacturing, supply continuity and cost improvement.

Skills

Design verification/validation

Test method development

Project management

Education

Bachelor of Science in Engineering (Mechanical or Bioengineering)

Master of Science in Mechanical or Biomedical Engineering

Tools

MS Project

Statistical analysis software

Job description

Position: R&D Engineer (Must Have Design Verification/Validation, Test Method, Projext Mgmt Exp)
Location: Tempe, AZ
Duration: 12 Months
Total Hours/week: 40.00
pay rate: $20-25/hr
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level of Experience: Entry Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)
Work hours: M-F 8:00a - 5:00p

3 Must Haves On The Resume

• 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)

Education Requirements

• 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

Job Description

• 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 minimum of three years of engineering experience.
• Demonstrated ability to utilize MS Project, statistical tools, and computer analysis.