Analysis Express ยท 21 hours ago
Sr. Design Engineer
Cincinnati Metro
Contract
Hybrid
Senior Level
5+ years expAnalysis Express is seeking a highly skilled Sr. Design Engineer to support ongoing product development, testing, and documentation for a leading regulated industry client. This role involves working cross-functionally with R&D, quality, and lab teams to drive product improvements and ensure compliance with regulatory and performance standards.
AnalyticsBig DataBusiness IntelligenceInformation Technology
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
5+ Years of relevant engineering experience
Deep knowledge of mechanical and thermal design
Data analysis skills
Validation protocol development experience
Ability to lead design decisions with full lifecycle accountability
Experience with 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 for automation and data workflows
Compliance with ASME Y14.5 standards for GD&T
Ability to track and report design iterations and test outcomes
Proficiency with GD&T and ASME Y14.5 Standards
Experience with Validation & Verification Protocols
Test Planning and Thermal/Mechanical Testing: Python scripting
Data Analysis: 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
Root Cause Analysis & Troubleshooting
Strong Technical Documentation skills
Cross-functional Collaboration skills
Preferred
Bachelor's or Master's degree in Mechanical Engineering or related field
5+ years of relevant engineering experience, preferably in regulated industries
Benefits
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.
11-50 employees
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