Design Engineer

Location: Onsite / Hybrid

Experience Level: 5+ Years

Employment Type: Full-Time

Position Summary

We are seeking a highly skilled Sr. Design Engineer to support ongoing product development, testing, and documentation for a leading regulated industry company. This role requires deep knowledge of mechanical and lifecycle design, data analysis, and validation protocol development. The engineer will work cross-functionally with R&D, quality, and lab teams to drive product improvements and ensure regulatory and performance compliance.

Key Responsibilities

Leads design decisions with full lifecycle accountability, ensuring requirements and design intent flow through verification, validation, manufacturing transfer, and sustaining support.

Owns design documentation and change control, using test results, manufacturing feedback, and field learnings to drive continuous design improvement in a regulated environment.

Design and refine validation protocols, including writing and updating test methods

Prepare and revise technical documentation including completion reports, Excel scripts, claims reports, and SOPs

Participate in cross-functional meetings to align engineering work with product and regulatory goals

Collaborate with software teams to automate reporting and improve test data workflows

Ensure compliance with ASME Y14.5 standards for GD&T and support manufacturing-related design updates

Track and report design iterations, part revisions, and test outcomes in structured formats

Key Skills & Tools

Design Engineering

GD&T and ASME Y14.5 Standards

Validation & Verification Protocols

Test Planning and Thermal/Mechanical Testing: Python scripting

Data Analysis: Minitab

Excel Automation & Reporting

Root Cause Analysis & Troubleshooting

SolidWorks or NX (for design updates and interpretation)

Strong Technical Documentation

Cross-functional Collaboration

Preferred Qualifications

Bachelor's or Master's degree in Mechanical Engineering or related field

5+ years of relevant engineering experience, preferably in regulated industries

Benefits

Competitive compensation based on role, experience, and market demand

Exposure to a wide range of engineering, software, and data-driven projects across industries

Opportunities to work with Fortune 500 clients and complex, real-world problems

Professional development through hands-on project work, mentorship, and skill building

Collaborative, team-oriented environment with direct access to leadership

Health, retirement, and paid time off benefits available based on role and employment @type

Analysis Express, Inc.

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