Mechanical Engineer

Millenniumsoft • Franklin Lakes, NJ

12d • Onsite

About The Position

We are seeking a Mechanical Engineer with a minimum of 3 years of experience in the medical device or other regulated industry. This role involves contributing to all project phases, with a focus on change control strategy, design verification strategies, and their execution. The position also requires supporting technical gap assessments, developing and executing remediation plans, and creating technical documentation such as drawings, protocols, reports, and work instructions. The engineer will apply engineering principles for design/analysis, perform statistical analysis, and develop sample plans. This is a Senior Level, Contract on W2 position for 12 months, requiring 40 hours per week, with a pay rate of $20-25/hr. The client is a Medical Device Company.

Requirements

• Minimum 3 years of experience in medical device or other regulated industry
• Experience with design controls activities and change management including DHF documentation is required
• Experience with technical gap assessments and remediation strategy development / execution is required
• Experience with test method development, validation strategy, and execution is required.
• Experience with design verification strategy development and execution is required
• Proficiency in solid mechanics/mechanics of materials and experience to statistical methods / tools is required.

Nice To Haves

• Experience in solid modeling (SolidWorks or equivalent) is desirable

Responsibilities

• Contribute to planning through all project phases with a focus on the change control strategy, development of design verification strategies, and execution of said strategies
• Support technical gap assessments, development of remediation plans, and execution of said plans
• Craft, edit, and interpret technical drawings and write protocols, reports, work instructions, presentations, etc.
• Apply engineering principles for design/analysis and complete statistical analysis and sample plan development.
• Demonstrate accountability for the successful and timely achievement of goals.
• Work independently with minimal guidance to complete objectives assigned by project team

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed