Exciting opportunity to join a truly innovative Medical Device Company located in Milford, OH to design and manufacture Medical Devices. This position is responsible for all aspects of the product development cycle from conception through development and into manufacturing transfer.
All Candidates must have Medical Device Engineering Experience and Strong Communication and Leadership Skills are essential!!!
- Bachelor's Degree or equivalent in Engineering or other relevant technical field
- Minimum of 7 years experience in Medical Device R&D or Product Development
- Highly innovative with the ability to work on own initiative
- Strong written and verbal communication skills
- Strong problem solving skills
- Medical device experience
- Experience with:
- CAD (SolidWorks preferred)
- Geometric Dimensioning and Tolerance
- Data Analysis
- Risk Analysis
- Ability to apply statistical methods
Not Required but Preferred
- Financial analysis experience
- Machining and prototype fabrication experience
- Experience with functioning in a highly regulated environment with working knowledge of ISO 13485 and FDA requirements
- Experience in designing components for plastic injection molding, extruding and metallic fabrication
- Experience in various manufacturing technologies used in component subassemblies and final product assembly
- The development of medical device products from concept through development, testing and manufacturing scale-up
- Design complex custom components, subassemblies and produce detailed part drawings and assemblies using CAD (SolidWorks preferred)
- Strong understanding and experience with material selection in applications that must meet functional requirements such as high stress, fatigue and sterilization compatibility
- Project Management responsibilities will include:
- Directing Design
- Chairing Project Meetings
- Developing and maintaining project plans, schedules and budgets
- Management of various outside services and component suppliers
- Apply technologies and processes to optimize product design
- Create specification, define testing protocols, monitor or execute testing qualification in accordance with Design Control and Validation Process.
- Perform engineering analysis such as Tolerance Studies, Finite Element Analysis and Design for Manufacturability.
- Design and fabricate conceptual and functional prototypes with the use of in-house manufacturing and rapid prototype sources.
- Facilitate problem solving activities, root cause analysis and other continuous improvement activities.
- Apply statistical problem solving methods using Minitab.
- Work together with Quality Assurance, Operations, Marketing, Vendors, Customers and Physicians.
- Adhere to design control procedures, general safety rules, company policies and procedures.
Interplex Medical is a contract design, developer and manufacturer of medical devices. Our capabilities include design, biomedical engineering, mechanical engineering, electrical engineering, process development, verification & validation, and manufacturing. We specialize in advanced catheter components, tissue closure & capture devices, and stent delivery systems. We have a significant expertise in minimally invasive devices used in general, endoscopic, gynecological, and vascular surgeries.
We are a Division of Interplex Holdings; with over 60 locations around the globe to meet the manufacturing needs of medical, automotive, and consumer electronics OEMs. This network includes several other ISO 13485 registered facilities in Scotland, Mexico and Florida.
Thu, 27 Apr 2017 05:14:32 PDT