Development Engineer III
As a key leader in the Consumables Medical Devices R&D team this position is responsible for Design Verification of assigned products. This position is responsible for providing product configuration and lifecycle management of the product design. Position is considered a subject matter expert in the application of international standards requirements for Infusion Sets and accessories.
ESSENTIAL JOB FUNCTIONS:
1. Analyzes, evaluates and plans methods for the solution of complex problems.
2. Develops project direction together with management.
3. Plans and directs major technical phases of projects with the highest level of accountability.
4. Responsible for directing assigned engineering and support staff.
5. Authors product design verification documentation intended for submission to global regulatory bodies.
6. Independently applies technical expertise in assisting customer adoption of new product (field support)
IF TRAVEL IS REQUIRED, INCLUDE PERCENT OF TRAVEL HERE: 5 %
OTHER DUTIES AND RESPONSIBILITIES:
1. Lead functional teams to achieve major milestones in assigned programs/projects.
2. Supervise contract labs in the execution of product testing
3. Perform competitive product evaluations
4. Identify product improvements and product cost/quality improvements
5. Perform other related duties as assigned or required.
Bachelor's Degree: Required-BS Biomedical or Mechanical Engineering
Master's Degree: Preferred
10/10+: AN EQUIVALENT COMBINATION OF EDUCATION AND RELEVANT EXPERIENCE CAN SUBSTITUTE FOR A DEGREE.
EXPERIENCE OR KNOWLEDGE REQUIRED IN THE DISCIPLINE OR FUNCTION: 10YRS EXP REQUIRED
* BS in Engineering. Advanced knowledge of materials and componentry and test methods associated with Infusion Sets governed by ISO 8536 and 1135. This position is responsible for verifying that the product design meets design requirements.
* Expertise in test method development and verification test strategy and protocols.
* Expertise in protocol development, analysis of results, and report writing.
* Experience in supervising laboratory testing and assuring compliance to test procedures.
* Position is considered a subject matter expert in the application of international standards requirements for Infusion Sets. In depth to expert ability to solve problems and communicate solutions effectively.