Summary of Position with General Responsibilities:
Design and develop innovative and/or low cost products/systems for BMD product lines. Responsible for planning and administration of the product/system through all development, laboratory test, clinical evaluation, market preference test and transfer to Process Engineering.
Essential Job Functions:
- Material qualifications - Testing
- Design and develop innovative and/or low cost products/systems to support both short and long term business plans.
- Invent prototype devices utilizing innovative material and process technologies to achieve concept objectives. Conduct design reviews and perform failure mode and effects analysis.
- Lead multi-functional product development teams by coordinating/delegating technical and administrative responsibilities, identifying critical action items and obtaining closure, and following corporate product development guidelines.
- Review new product concepts; and in conjunction with a product development team, develop performance specification and project schedules.
- Develop laboratory tests and protocols to assure conformance of prototype devices to performance specifications, F.D.A. regulatory and biocompatibility requirements.
- Interface with Process Engineering for the fabrication of devices to support both animal and human clinical evaluation to include:
- Process definitions - Documentation
- Material qualifications - Quality test requirements
- Evaluate device performance through animal and/or human clinical investigation; and, as required, implement appropriate product changes to include revision of performance specifications.
- Transfer new products/systems to Manufacturing to include:
- Technical instruction
- Interface with vendors, consultants, and customers.
- Provide technical direction to manufacturing during pilot production, as well as on currently manufactured products.
- Continuing Education
- Professional association
- Communicate project status, through verbal and written reports and schedules, to management.
- Maintain accurate and timely records of the development of products according to laboratory notebook protocols.
- Hires and trains Engineers and Technicians including performance appraisals and salary review.
- Maintain a current status in field of expertise through:
- Support of all development activities via application of technical expertise.
Education and/or Experience:
- 10 years previous experience as a development engineer.
- Previous experience with catheters or processing of small plastic components preferred.
- Minimum of a 4 year technical degree, preferably in Mechanical, Plastics, Chemical, or Biomedical Engineering.
C. R. Bard - 17 months ago
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...