Mechanical Engineer
Wilmington, OH
80k/year - 100k/year
January 9, 2025
Applicants: 0
Interviewing: 0
Hired: 0
Direct Hire
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About the Job
Gentis Solutions is looking for a Mechanical Engineer to join our client's team. Client-specific benefits are available and will be discussed in detail during your interview.
Compensation for this position ranges from 80k/year - 100k/year per year, based on experience. Payment is bi-weekly and is based on all hours worked, without eligibility for overtime.
This position requires the individual to be located in the Wilmington, OH area.
Requirements
- Engineering design team member of electro-mechanical pre-hospital patient handling products and sub-systems
- Design and re-design of FDA, ISO 13485, CE, ISO 14971, MDD 93/42/EEC, MDR compliant medical devices
- Participate in Engineering Change Order and/or Phase-Gate processes for assigned programs to include QMS compliance
- Participate in the formulation of design specifications, material specifications, concept, prototyping, tolerance stack-ups, DFM, DFA, DFS, vendor integration, design reviews, FMEA development, usability assessment, design transfer readiness and introduction
- Accountable for design history file and technical file documentation and other controlled documents under regulatory framework
- Review product verification and validation test plans and results. Provide feedback to development teams
- Work with test engineering, quality and regulatory to ensure products maintain certification to various standards
- Lead communication on assigned programs and provide issue escalation support to internal and external customers
- Maintain and update design drawings and models utilizing CAD; Solidworks experience is required
- Conduct design reviews for updated legacy or new product designs
- Assist in diagnosing field issues and developing corrective actions
- Ensure compliance with all regulatory and compliance activities within prescribed area
- Develop solutions to improve product quality and reduce product cost