This position is responsible for system development and improvement along with managing projects with divisional impact. This position is of a technical rather than managerial nature, but may supervise other engineering personnel. Individuals in this position will typically lead a technical group and may manage major projects in more than one technical area. In addition, this position may provide technical expertise to other groups or projects. *
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:
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.
Potential Task Assignments within the scope of this position
- Consultant/Corporate expert
- Develops Innovative ideas for the organization
- Technical expertise in a specific area
- Broad business and technical understanding
- Coach/Mentor to other engineers
- Influences Others across organization
- Results Oriented
- Critical Decision Maker in areas of engineering and business needs
- Project Leader
1. Maintains a professional working relationship with internal & external customers.
2. Participates and leads cross-functional teams.
3. Provides technical support on device coating selection, process optimization, and scale-up.
4. Develops chemical, physical, functional and inspection test requirements to assure specifications & regulations are met.
5. Oversees in-vitro and in-vivo tests for device efficacy and safety.
6. Writes and approves protocols, reports and data.
7. Manages testing outlined in protocols and test methods
8. Manages/develops validation studies on equipment & processes.
9. Leads failure investigation teams.
10. Develops and presents training in area of expertise.
11. Manages project planning, budgeting, scheduling and tracking.
12. Plans and coordinates engineering test builds.
13. Analyzes problems in design, process and test development. Recommend/implement cost effective solutions.
14. Prepares and presents oral and written project updates and technical discussions.
KNOWLEDGE AND SKILLS:
1. Ability to generate and present engineering decisions/proposals
2. Strong interpersonal and supervisory skills
3. Advanced engineering/ chemistry skills/specialized technical expertise
a) Medical device coatings/ biomaterials/ polymer chemistry
b) Microbiology and/or hemocompatibility
c) Design Controls
d) Technology Transfer
e) Process optimization and scale-up
g) Clinical trials, animal, and in-vitro testing.
4. Preferred Accomplishments related to technical expertise
a) Technical Publications/Certifications
b) Patent/industry awards
c) National Committee/Association Leadership
5. Ability to train, create and critique training
6. Advanced problem solving ability/root cause analysis.
7. Ability to create, review and coordinate test protocols and reports
8. Excellent oral and written presentation skills
9. Ability to lead and produce results in a cross-functional team environment
10. Comprehensive understanding of regulatory environment
This position requires:
The above experience must include 5 (five) years’ effective project management skills with the ability to produce results.
- a Bachelors degree in science or engineering with 10 (ten) years of engineering experience within the medical device or equivalent industry OR
- Masters degree with 8 (eight) years of engineering experience within the medical device or equivalent industry
The incumbent must demonstrate the ability to perform the essential functions of the job as outlined in the duties and responsibilities. Must also understand and follow company procedures and regulatory requirements
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...