Join a rapidly growing company that is seeking a full-time Mechanical Engineer for their Cincinnati, Ohio location. The company was founded in 2004, as a full service contract manufacturer of medical devices. The company provides product design and development services, prototyping, and manufacturing services to medical device OEMs.

MUST have a background in the Medical Device Industry.

Use your experience in designing surgical instruments in the fields of cardiology, cardiovascular surgery, endoscopy, laparoscopy and orthopedics. Knowledge of catheter based products and mechanical disposable devices are desirable.

RESPONSIBILITIES
Design and develop instruments for a wide variety of device OEMs
Communication with customers and surgeons understanding the clinical issues
Defining the design parameters
Ensuring the correct product is provided to the customer

The company has over 40+ years of Medical Device involvement has included all facets of design, prototyping, development, and project management for markets including minimally invasive surgical devices, ophthalmic devices, cardiovascular instrumentation and many more. If given the opportunity client can truly overcome and deliver the expectations that this industry requires.

Requirements
Ensure compliance with FDA, and to support 510(k) submissions or IDE clinical studies.
Create and maintain project plans and FDA compliant Design History Files (DHF) for each project.
Develop appropriate mechanical test protocols and coordinate the activities required to fabricate test parts and complete mechanical testing.
Work in conjunction with manufacturing during the design stages to incorporate manufacturability into the product designs.
Responsible for the all designs from concept development through product launch.
Perform bench-top development, prototyping, modeling and testing with in house facilities.
7 to 10 years experience in the Medical Device field developing surgical devices and or implantable appliances.
Strong communication and interpersonal skills, with the ability to interact with various customers and surgeons
Experience in the creation of solid models (SolidWorks), analyzing designs (COSMOS) and detailed drawings for new designs, maintain design control documentation and project files adhering to FDA and ISO design control requirements.
Bachelor’s degree in Mechanical or Biomedical Engineering required.

Contact Information:

Contact: Jeff Thompson
Email: jthompson@tescareers.com