Bard Electrophysiology Division is a global leader in the development of products used to diagnose and treat patients with cardiac arrhythmias. We are committed to technological innovation and to advancing the delivery of health care. Located in Lowell, Mass., we are a division of C.R. Bard, Inc., a recognized leader in the medical device industry that has celebrated over 100 years in business.
We are seeking an Electrical Engineer II to design develop and test new hardware products and systems for diagnostic and therapeutic interventions directed towards application in the field of electrophysiology. You will be responsible for planning and administration of the product/system through all development phases to include: prototype development, vendor management, laboratory test, human factors engineering, physician interface, clinical evaluation and post commercialization support.
Summary of Position with General Responsibilities:
The responsibilities for this position will include but not be limited to:
In addition to the essential functions listed above, you may be required to perform other non-essential functions. Employees are required to follow all other job-related instructions and to perform other job-related duties requested by their supervisor.
- Experience in medical device design controls, or at a minimum, those of other regulated industries.
- Proficient in the use of risk analysis techniques such as Design Failure Modes and Effects Analysis (DFMEA), Risk Analysis, Edge-of-Failure Analysis, Fault Tree Analysis, etc..
- Understanding of medical device standards and quality systems, or at a minimum, those of other regulated industries.
- Demonstrated ability to translate new product concepts into performance specifications in accordance with established procedures and policies.
- Ability to read schematics and understand electrical component data sheets.
- Experience in analog and digital circuit design and test techniques.
- Working understanding of software and firmware systems and testing.
- Demonstrated ability to develop and write formal test procedures and reports including those of black and white box to assure conformance of prototype devices to performance specifications, as well as Federal Food and Drug Administration and International regulatory requirements.
- Experience in interfacing and successful collaboration with various external electronics developers and manufacturers. Experience with offshore entities is a plus.
- Ability and willingness to work in a hands on capacity including the use of electronic test and measurement tools, and development and fabrication of test circuits and fixtures.
- Aptitude and willingness to learn and understand the basics of electrophysiology.
- Experience in human factors engineering a plus.
- Experience with design and development of single use disposables a plus.
- Ability to work and effectively communicate across functions such as marketing, quality, clinical and regulatory.
- Evaluate device performance through animal and/or human clinical investigation.
- Provide consultation, troubleshooting and reporting on technical problems and field failures as related to currently manufactured products.
- Prepare project status reports including experience with Microsoft Project.
- Maintain accurate and timely records of the development of products according to laboratory notebook protocols.
- Maintain a current status in field of expertise through: continuing education, symposia, and professional associations.
The basic qualifications for this position will include, but not be limited to:
C.R. Bard is an Equal Opportunity Employer
- A minimum of a Bachelor of Science Degree in Electrical Engineering or equivalent experience.
- A minimum of five years experience preferably in medical or other regulated industry
- Ability to effectively communicate with medical professionals and interface with various levels of the organization.
- Strong written/verbal communication skills.
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...