This position develops and implements test methods, performs chemical and analytical measurements of medical device materials, interprets data and supports the development of new devices.
The ideal candidate must be able to work in a team oriented, fast paced environment. Bard Access Systems is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
Summary of Position with General Responsibilities:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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.
• Responsible and effective Team Member
• Ownership of projects
• Technical Competence
• Internal Collaborator
• Works Independently
• Results Oriented
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 & external customer and support staff
3. Participates and/or leads testing for projects.
4. Provides technical support on components, analytical methods, systems and equipment.
5. Develops chemical and device test requirements to assure specifications & regulations are met.
6. Writes, reviews and approves protocols, reports and data.
7. Conducts testing outlined in protocols and test methods
8. Executes 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 & 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 laboratory and instrument scheduling.
16. Analyzes problems in design, process and test development.
17. Prepares and presents oral and written project updates and technical discussions.
18. Develops and implements procedures to provide easy to follow instructions.
KNOWLEDGE AND SKILLS:
1. Ability to make and present analytical testing decisions
2. Strong interpersonal skills
3. Specific specialized analytical chemistry skills such as
a) Test method development and validation
b) Operation of analytical instrumentation
c) Analyze and optimize existing processes and ability to create new processes
d) Organization and interpretation of data using statistical principles
e) Experience with thermal analysis equipment such as TGA, DSC, and DMA
f) Experience with separations and chemical identification equipment such as FTIR, HPLC, and GPC
g) Material Science and Bioengineering principles
4. Ability to create and provide training
5. Demonstrated comprehension of basic comparative statistics
6. Software application skills
7. Problem solving ability
8. Ability to create, review and coordinate test protocols and reports
9. Ability to generate test proposals and testing plans
10. Oral and written presentation skills
11. Ability to work in cross functional teams
12. Understanding of regulatory environment
This position requires:
• an Associate technical degree with 5 (five) years of chemical laboratory experience within the medical device or equivalent regulated industry OR
• a Bachelor degree in science or engineering with 2 (two) years of laboratory experience within the medical device or equivalent regulated industry OR
• Masters degree OR
• Demonstrated knowledge of laboratory principles through 10 (ten) years of laboratory experience within the medical device or equivalent regulated industry
The incumbent must demonstrate the ability to perform the essential functions of the job as outlined in the duties and responsibilities.
C. R. Bard - 10 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...