2007-108 Engineer II **

Description
JOB SUMMARY:
This position is responsible for developing the next generation sterile welding devices and ancillary products for the Transfusion/Biotech Business, as well as developing modifications and improvements to the current SCD/TSCD product line. The position includes work with contract vendors, the ability to plan and run multiple projects, and the ability to perform tasks in a time constrained manner. Responsibilities include investigating, planning, and implementing the more complex improvements in products and manufacturing processes that directly effect performance, safety, quality, and productivity of manufacturing, with the end result of developing and producing new and better quality products more efficiently.

DUTIES AND RESPONSIBILITIES:
1. Maintain and follow proper ISO procedures and GMP requirements, where required.
2. Work on developing modifications and new products for the SCD/TSCD product line, including working with marketing and sales to understand customer need, and working with outside vendors, or with Terumo Europe and Terumo Japan Engineers.
3. Plan and implement specified projects to be completed including organizing and leading members of various sections, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, project plans, etc.
4. Provide engineering expertise in the design, fabrication, development, installation and qualification of equipment that may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of equipment.
5. Provide leadership and have direct responsibility, or work with Manufacturing or Marketing, for the proper planning and implementation of projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.
6. Research and implement cost reduction projects.
7. As appropriate to the required development task, this position must insure compliance with plant-wide calibration systems and drawing control/document control system, as well as interaction with notifying/reviewing agencies (ISO, UL, etc.).
8. Work with Marketing and outside vendors and appropriate customer focus groups to insure that product definitions meet market needs. Work with QA and RA to insure that proper design vetting and documentation is provided.
9. Perform other job related duties as assigned.


Position Requirements
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
1. Typically requires a four year degree in an engineering discipline coupled with 3-5 years experience in a pilot or manufacturing environment for designing, specifying, fabricating, assembling, and debugging electro-mechanical products and machinery or manufacturing processes.
2. Ability to create and work from engineering drawings
3. Good analytical and problem solving skills
4. Sound knowledge of statistical techniques, engineering drafting and personal computer knowledge
5. Good communication skills both verbal and written, and ability to work within a team development and support operation.
6. Ability to lead project work, and to crystallize product requirements in an understandable manner.
7. Knowledge and utilization of electronic equipment and tools in fabricating, as well as laboratory testing, inspection system, etc.
8. Position exists in a mixed shop/office environment. Travel to vendors, other company engineering groups, or customers required, and may require up to 15% travel, depending on project work.
9. Must have, and maintain, a good attendance record and good performance evaluations, with no disciplinary actions during the past twelve months
10. Should have good prior safety record and maintain safety record

Preferred Qualifications:
1. Ability to work on developing electro-mechanical equipment in the biomedical field a plus, and experience in software development helpful.
2. Knowledge of GMP/FDA regulations
3. Experience working in a regulated environment


Educational Requirements
Requires a 4 year degree in an engineering discipline.

Full-Time/Part-Time
Full-Time

Shift
First

Department