Mechanical Engineer

Position Title:
Mechanical Engineer (PHIAJP)

Location:New Kensington Pennsylvania USA 15068 - hybrid

Duration:12 months contract to start (extendable and potentail to convert)

This is a Mechanical Engineer role in the medical device industry (likely focused on hardware product development). The engineer will be responsible for designing, testing, improving, and supporting medical device components throughout the product lifecycle while ensuring compliance with quality and regulatory standards.

The Mechanical Engineer will:

• Design and develop mechanical components for medical devices.
• Create engineering solutions for complex hardware problems.
• Plan and execute verification and validation testing to ensure products work safely and meet specifications.
• Troubleshoot technical issues during product development and manufacturing.
• Work with suppliers to evaluate and approve components.
• Monitor product performance and recommend design improvements.
• Ensure products comply with company quality standards and medical device regulations.
• Prepare technical documentation, reports, and design reviews.
• Collaborate with cross-functional teams such as R&D, Quality, Manufacturing, Regulatory Affairs, and suppliers.
• Mentor junior engineers and help improve engineering processes.

Education

• Bachelor''s degree in Mechanical Engineering.

Experience

• At least 3 years of mechanical/hardware engineering experience
  , preferably in medical devices or another regulated industry.

The ideal candidate should have experience with:

• Mechanical/Product Design
• Product Development
• Hardware Engineering
• Verification & Validation (V&V) Testing
• Root Cause Analysis & Troubleshooting
• CAD Design (Solid Works, Creo, CATIA, etc.)
• Technical Documentation
• Design Reviews
• Requirements Analysis
• Lifecycle Management
• Continuous Improvement
• Regulatory Compliance (FDA, ISO 13485, IEC standards is a plus)
• Working with suppliers/vendors

A typical day may include:

• Designing a new medical device component.
• Reviewing engineering drawings and specifications.
• Running mechanical tests to verify product performance.
• Investigating why a prototype failed testing.
• Working with manufacturing to resolve production issues.
• Meeting with suppliers about component quality.
• Documenting test results and design changes.
• Participating in design review meetings.
• Collaborating with quality and regulatory teams before product release.