Product Development Engineer (Design verification/validation, Project Mgmt Exp is Required)

MillenniumSoft Inc; Tempe (AZ); On-site; USD 71,635,000 - 85,962,000; Full time

Job summary

MillenniumSoft Inc. in Tempe, AZ seeks a Product Development Engineer (Design verification/validation, Project Mgmt Exp required).

The 12-month, 40-hour week contract on W2 involves leading verification activities and cross-functional collaboration with focus on EU MDR compliance. Ideal candidates have a mechanical or bioengineering background with 3–4 years (BS) or 2 years (MS) of relevant experience, and strong project management skills.

Qualifications

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

Responsibilities

• Assist remediation of existing products to meet EU MDR for 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; supports quality, manufacturing, supply continuity and cost improvement.
• Participate in executing technical and/or cross-functional project work.
• Develop and execute test methods specifying measurement equipment, test setup, 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 project updates and technical discussions to stakeholders.
• Creates, executes, and tracks project plans in MS Project to completion while maintaining budget.
• Ensure compliance with client quality policies and safety regulations.

Skills

Design verification/validation

Test method development

Project management

Education

B.S. in Mechanical or Bioengineering

M.S. in Mechanical or Bioengineering

Tools

MS Project

Statistical analysis software

Job description

Position : Product Development Engineer (Design verification/validatio, Project Mgmt Exp is Required)

Location : Tempe, AZ

Duration : 12 Months

Total Hours/week : 40.00

pay range -$25-30/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.