Analysis Express ยท 4 days ago
Mechanical Design Engineer
Analysis Express is seeking a highly skilled Mechanical Design Engineer to support ongoing product development, testing, and documentation for a leading regulated industry client. The role involves leading design decisions, ensuring compliance with regulatory standards, and collaborating cross-functionally to drive product improvements.
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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
Qualification
Required
4+ Years of experience in Mechanical Design Engineering
Knowledge of mechanical and lifecycle design
Data analysis skills
Validation protocol development
Ability to lead design decisions with full lifecycle accountability
Ownership of design documentation and change control
Ability to design and refine validation protocols
Experience in preparing and revising technical documentation
Participation in cross-functional meetings
Collaboration with software teams
Ensuring compliance with ASME Y14.5 standards for GD&T
Tracking and reporting design iterations, part revisions, and test outcomes
Proficiency in GD&T and ASME Y14.5 Standards
Experience with CAD: SolidWorks
Experience with Validation & Verification Protocols
Test Planning and Mechanical Testing experience
Data Analysis skills using Minitab
Familiarity with measurement system analysis (Gage R&R)
Experience working in regulated or quality-driven environments
Proficiency with SolidWorks or similar CAD tools
Experience supporting Design History File (DHF) documentation
Excel Automation & Reporting skills
Root Cause Analysis & Troubleshooting skills
Strong Technical Documentation skills
Cross-functional Collaboration skills
Preferred
Bachelor's or Master's degree in Mechanical Engineering or related field
4+ 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
Company
Analysis Express
Analysis Express specializes in engineering, analytics, big data, business intelligence, data warehousing and related services.
H1B Sponsorship
Analysis Express has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Early StageCompany data provided by crunchbase