This position is responsible for conducting engineering studies for process improvements and validations. This position designs, develops and implements new products, processes, test methods and equipment. Bard Access Systems is an Equal Opportunity Employer.
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
Scope
- Consultant/ Department expert
- Technical Expertise
- Organizational credibility and knowledge
- Guides and Develops Others
- Influences and directs others within Department
- Results Oriented
- Project Leader
- Business Knowledge
Potential Task Assignments within the scope of this position
1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation
2. Maintains a professional working relationship with internal and external customer and support staff
3. Participates and/or leads cross-functional teams
4. Provides technical support on components, material methods, systems and equipment
5. Develops physical and functional test requirements to assure specifications & regulations are met
6. Writes and approves protocols, reports and data
7. Oversees testing outlined in protocols and test methods
8. Coordinates/develops validation studies on equipment & processes
9. Executes design controls
10. Analyzes design inputs
11. Conducts complaints investigations
12. Understands and follows company procedures and regulatory requirements
13. Participates in and provides input to training on department and division procedures, and policies
14. Prepares and submits for approval requests for project funding. Participates in project planning, budgeting, scheduling and tracking
15. Plans and coordinates engineering test builds
16. Analyzes problems in design, process and test development. Recommend solutions
17. Prepares and presents oral and written project updates and technical discussions
18. Develops and implements procedures to provide easy-to-follow instructions
Research and Development
Responsible for concept generation, design, development and evaluation of new products, materials and technologies
This position requires:
- an Associate technical degree with 8 (eight) years of engineering experience within the medical device or equivalent regulated industry OR
- a Bachelor degree in science or engineering with 4 (four) year of engineering experience within the medical device or equivalent regulated industry OR
- Masters degree with 3 (three) years of engineering experience within the medical device or equivalent regulated industry OR
- Demonstrated knowledge of engineering principles through 15 (fifteen) plus years of engineering experience within the medical device or equivalent regulated industry
The above experience must include demonstrated effective project management skills
The incumbent must demonstrate the ability to perform the essential functions of the job as outlined in the duties and responsibilities