Job Description
Job Description
The Engineering Intern is part of the Research and Development / Continuation Engineering team at Scanlan International. They will work on project teams to develop new and support current surgical instruments. This will involve gathering physician input, generating new produce ideas, create and revise computer three dimensional models and drawings using SolidWorks and AutoCAD, performing product evaluations, root cause analysis, research solution, design testing fixtures, verification and validation testing and preparing design control documentation.
Position Responsibilities / Essential Functions :
Percentage Time
Accountability
Design Products using CAD (AutoCAD, Solidworks) :
- Design products using Solid Works and / or AutoCAD.
- Translate customer inputs into design / product specifications.
- Create novel design solutions to meet customer’s unmet or under met needs.
- Collaborate with team to coordinate internal and external resources to translate CAD models to prototypes using SLA, SLS or machined models.
Follow Quality System / Design Control Processes :
Develop product concepts following specific Design Control procedures per ISO and FDA utilizing processes such as DOE and FMEA, amongst others.Create and maintain records and files that comply with GMP and ISO Requirements such as Device Master Record (DMR), Device History File (DHF), Design History Record (DHR) and Technical Construction Files (TCF).Generate Drawings and Specifications :
Prepare / Revise / Review drawings for engineering, production and quality control as requested.Prepare / Review prototype and test fixture drawings as requested.Prepare / Review drawings of existing product to document product specifications as requested.Maintain drawings within the Device Master Record (DMR)Revise drawings using the Document Change Request (DCR) processPerform Product Design Verification and Validation Testing
Write protocols and reportsPerform testing and collect dataSummarize test data and document resultsQUALIFICATIONS :
Required Qualifications :
Education :
Currently enrolled in mechanical, or biomedical engineering Bachelor of Science degree.Experience :
Experience with computer aided drafting (CAD) systems.Skills :
Ability to read and understand engineering drawings.Software skills to include Microsoft Word, Excel, Power Point, AutoCAD, Solid Works, and MS Project.Preferred Qualifications :
Experience :
Materials and processes relating to stainless steel, titanium, thermal plastics, silicones including machining, forging, heat treating, welding and molding.Experience with AutoCAD, SolidWorks and MinitabExperience working on design project teams.Success Factors / Abilities :
Work with a dynamics product development team to develop new surgical instruments.Develop engineering and product design skills working within a FDA and CE compliant design control process.Gain knowledge of FDA Quality Systems including cGMP and Design Controls, ISO 13485 requirements along with FMEAs, DOEs and Risk Assessment methods.
