Mechanical Engineer

Job Title
:
Mechanical Engineer – Medical Devices

Location
:
Minneapolis, MN, USA

Duration
: 12-Month W2 Contract

Shift Timings
:
Monday – Friday | 8:00 AM – 5:00 PM

Job Description

We are seeking a Mechanical Engineer to support product development, sustaining engineering, and manufacturing activities within a regulated medical device environment. The ideal candidate will have hands‑on mechanical engineering experience, exposure to medical device standards, and the ability to work cross‑functionally with Quality, Manufacturing, and R&D teams.

• Support design, development, and modification of mechanical components and assemblies for medical devices
• Assist with engineering documentation including drawings, BOMs, ECOs, and technical reports
• Perform tolerance analysis, material selection, and basic stress or thermal evaluations
• Support prototype builds, testing, verification, and validation activities
• Participate in root cause analysis and failure investigations
• Collaborate with Manufacturing Engineering to support production issues and process improvements
• Ensure compliance with FDA regulations, ISO 13485, and internal quality system procedures
• Assist with risk management activities including DFMEA and PFMEA
• Support change control and design transfer activities

• Bachelor’s degree in Mechanical Engineering or related discipline
• 1‑3 years of mechanical engineering experience (medical device industry preferred)
• Proficiency with CAD tools such as Solid Works, Creo, or AutoCAD
• Basic understanding of GD&T and engineering drawings
• Familiarity with regulated environments and documentation practices
• Strong analytical, problem‑solving, and communication skills
• Ability to work onsite during standard day shift hours

• Experience working with Class I or Class II medical devices
• Exposure to validation, verification, or testing protocols
• Knowledge of FDA 21 CFR Part 820 and ISO 13485 standards
• Experience supporting manufacturing or sustaining engineering teams

Associate

Contract

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research