Mechanical Design Engineer
Mechanical Design Engineer
Posted on :
17-03-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
17-03-2025
Job Description
Position: Mechanical Design Engineer
POSITION SUMMARY:
The Mechanical Design Engineer reports to Engineering Management and works closely with functional and cross functional team members in the global company including those in product management marketing sales finance operations quality and regulatory. The Mechanical Design Engineer is responsible for all product development and engineering sustaining activities for assigned programs.
ESSENTIAL FUNCTIONS:
- Engineering design team member of electromechanical prehospital patient handling products and subsystems.
- Design and redesign of FDA ISO 13485 CE ISO 14971 MDD 93/42/EEC MDR compliant medical devices.
- Participate in Engineering Change Order and/or PhaseGate processes for assigned programs to include QMS compliance.
- Participate in formulation of design specifications material specifications concept prototyping tolerance stackups 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.
QUALIFICATIONS:
- Bachelor of Science degree in Mechanical Engineering
- 3 to 5 years of related engineering experience.
- Exposure to and/or basic engineering understanding of principles associated with electromechanical/hydraulic devices to include DC motor pump cylinder valve body and control system design
- Exposure to and/or basic engineering understanding of basic design principles related to injection molding metalworking machining castings aluminum extrusions welding battery technologies and electrical systems (PCB/Firmware/Software)
- Exposure to and/or basic engineering understanding of ISO and FDA regulated design control requirements for medical devices
- With direction ability to make decisions in regard to compliance product reliability and analysis of testing methodologies
- Working knowledge of SolidWorks CAD Software as it pertains to mechanical system layout
- Working knowledge of GD&T/ANSI standards
- Strong product affinity and results orientation
- Perform structural analyses of components and assemblies using finite element analysis methods.
- Experience developing and/or supporting medium to high volume products
PHYSICAL/SAFETY/TRAVEL REQUIREMENTS:
Job demands include prolonged sitting may need to stoop bend and stand as appropriate
Requires coordination of hands and/or eye/hand/foot
Meets cognitive demands to include visual discrimination/memory auditory discrimination/memory reading ability independent decision making and retention of specific knowledge
Requires use of safety glasses in designated areas
Ferno is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation genderidentity national origin protected veteran or disability status.
Employment Type
Full Time
Key Skills
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