The Mechanical Engineer I position is located at Bard Medical Division in Covington, GA.
Summary of Position with General Responsibilities:
This position leads project teams and/or provides technical effort toward the development and introduction of new products and line extensions into the medical device market. The position plays a key role in leading teams through the development and FDA compliance issues involved with medical devices. The position requires the development of an understanding of the current medical device markets and customer requirements along with the ability to interact with doctors and other medical professionals.
Essential Job Functions:
Assists in specifying performance criteria against which a candidate product design must be challenged.
Presents prototypes/proposed products in marketplace and draw conclusions relative to user attitudes/acceptance of the device/system.
Assists in ensuring the QSR compliance of design control process in product development.
Knowledge or ability to learn DOE’s, process validations, and other QSR requirements.
Documents the new product development process; e.g., create specifications, define testing protocols, prepare comprehensive performance reports, and comply with QSR requirements.
Performs patent searches, read patents, and comprehend patents.
Brainstorms new inventions or solutions to current problems.
Capable in performing hand calculations and FEA
Education and/or Experience:
- Demonstrated track record of project and team leadership in a fast-paced product development environment
- Foundation and experience in medical product design, including some 3-D CAD experience (SolidWorks preferred)
- Working knowledge of design control, FDA regulations, and ISO standards for medical devices
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, coaching, and team building
- Strong questioning and problem-solving skills
- Experience with prototyping techniques (e.g., SLA, machining, RTV molding, etc) and various manufacturing processes (e.g., injection molding, machining, plastic and metal processing, assembly techniques, etc)
- Proficient in the use of software programs such as MS Word, Excel, PowerPoint, Outlook, and Project, or equivalent programs
- Experience with handheld mechanical devices and biomaterials is preferred
- Understands GD&T principles
Bachelor of Science degree in Mechanical, Industrial Engineering, or related Engineering field, from an accredited four-year college or university.
1-3 years of experience in consumer/medical product and process development
Sustaining Engineering experience a plus
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.