Location : Clifton NJ US 07013
Job Type : Direct
Reference Code : 21064-BZ1
Compensation : 80000.00 - 100000.00 USD/YEAR
Start Date : 06/07/2022
Hours : Full Time
Required Years of Experience : 6
Required Education : BS Mechanical Engineering
Travel : No
Relocation : No
Job Industry : Engineering
Job Description :
- Permanent position for a Mechanical Engineer for design of medical devices and medical equipment, specifically for pneumatic design projects.
- Interprets customer specifications to define requirements for mechanical designs.
- Applies the 3D CAD system to create mechanical design and drawings.
- Develops detailed fabrication and assembly drawings and performs tolerance analysis.
- Develop prototypes for design evaluation.
- Preparation Engineering Change Notices.
- Generation / execution of Process Validation Protocols/Reports.
- Preparation / Chairing Design Reviews including preparation / distribution of meeting minutes.
- Troubleshoot and resolve design & processing issues.
- Design documentation using electronic documentation systems.
- Develops & execute design verification protocols and technical reports.
Required Qualifications :
- BS Mechanical Engineering
- Minimum 6 years experience with mechanical design.
- Experience with Solidworks and/or Pro/ENGINEER
- Experience in medical equipment / device design with particular experience in electromechanical, electro-pneumatic and pump design.
- Knowledge in medical device industry regulations and practices - ISO 13485, ISO 7198 & GMP.
- Design for Manufacturability and Assembly experience, DFM&A (cost/tooling/process considerations).
- Experience with design of molded plastic or cast parts, sheet metal, Pneumatics, and cabling.
- Experience with Verification / Validation testing and and ability to create test documentation (protocols).
- Experience with GMP and operating in a 21 CFR 820 compliant work environment.
- Familiarity with dimensioning and tolerancing, thermal and structural analysis.
Contact: Bill Zukowsky