Responsible for the conception, design and development of new and improved products. Coordinates and implements projects through all phases of design and development.
Summary of Position with General Responsibilities:
Davol Inc., and C.R. Bard, Inc. are Affirmative Action/Equal Opportunity Employers, M/F/D/V.
- On a project management assignment basis, uses the concurrent engineering process to design and develop new and improved medical devices.
- Reviews design objectives with marketing and management and assures product design meets objective.
- Coordinates the development of prototypes and lab testing samples and fixtures.
- Performs and/or supervise development and 510(k) testing.
- Formulates and approves product specifications, materials, assemblies and processes.
- Responsible for design control activities, including user needs assessment, product performance specifications, hazards analysis, DFMEA, design verification and validation
- Conducts and/or supports design review meetings in accordance with procedures.
- Researches outside market for information on new materials and processes related to the design and the improvement of the Davol product lines.
- Works concurrently with Manufacturing Engineering, Manufacturing and Quality Engineering groups in starting up production of new and improved products.
- Functions as team leader on assigned projects typically within larger scaled programs.
- Responsible for creating and managing project plans and schedules developed with project teams.
- Supports maintenance of business and regulatory submission requests as needed.
- Responsible for communications to supervisor and all levels of management.
Additional Desirable Qualifications Skills and Knowledge:
- BS Mechanical Engineering / Biomedical Engineering
- Minimum of two years experience (BS) or minimum one year experience (MS) as, Product Development Engineer, Biomedical Engineer, or Product Design Engineer in the surgical, disposable medical products or related industries. Background and knowledge of test method development.
- Knowledge of current FDA medical device regulations including IDE and GMP requirements.
- Must be capable of handling a variety of projects at the same time.
- Must have good communications skills to deal with all levels of technical and operating management.
- Broad knowledge of use of medical disposable devices and equipment.
MS Degree preferred.
Background and knowledge of all machine shop practices, plastic molding and forming equipment and plastic component assembly techniques preferred.
C. R. Bard - 15 months ago