Manufacturing Design Engineer

Our client is a leading manufacturer of Point-of-Care in-vitro diagnostic instrumentation and consumable test devices used in hemostasis management in the hospital and home markets. They also manufacture high volume, automated skin-incision and blood collection devices for the collection of small blood samples. They are committed to developing, manufacturing & marketing safe, easy to use, and reliable products that are used by nurses, doctors & medical practitioners where care is provided to patients.  Currently, our client, who is located in Central New Jersey, has a select opening for a Manufacturing Design Engineer reporting to the Vice President of Manufacturing. This is a key manufacturing engineering position, which along with the rest of the Engineering staff, assists in supporting the growth of production operations.  As directed, the engineer develops/implements/manages projects that usually involve manufacturing process quality improvements, required volume scale-ups, and process cost reductions.

   

 

DUTIES/RESPONSIBILITIES:

 

·  Create/implement programs for volume demand increases and cost reduction improvements reducing manual labor or improving process/equipment yield.

·  Support the associated engineering staff and manufacturing operations personnel as required, including the training of production operators regarding new equipment/processes.

·  Support installation, qualification, and validation of new equipment and processes, including the writing and executing of feasibilities, protocols/reports, and SOPs.

·  Coordinates with vendors and suppliers, including the procurement of project related materials and components.

·  Provides project proposals, budgets, and technical and financial justifications.

·  Communicates/interacts with the machine shop regarding production problems, process opportunities, and equipment fabrication schedules.

·  Establishes a safe, secure, controlled and efficient mechanical operating environment.

·  Machine and tooling design utilizing Autocad/Solidworks

 

 

EDUCATION AND EXPERIENCE:

 

·  A college Bachelor degree in Mechanical Engineering.

·  Minimum of 10 years of diverse manufacturing/engineering experience, including manufacturing experience within a medical device environment.

·  Familiar with FDA GMP Requirements, ISO 9000 Standards and OSHA.

·  Competent in writing/performing validations with in a GMP and ISO9001 regulated environment.  Capable of statistical analysis and sampling preferred.

·  Technically proficient in reading engineering drawings, schematics, specifications, tolerancing and bills of materials.

·  Must be able to communicate/ work well with production personnel and have project management experience.

·  Must also be comfortable with automation development (batch and continuous methods), including processing such as reagent filling/dispensing, drying, assembly, printing, inspection, pouching, and packaging

·  Knowledge of vision and computer systems is desirable.

 

This is an excellent position located in Central New Jersey and offers an excellent salary and benefits package.  Local candidates only need apply as relocation is not provided.  This is a highly visible spot and my client is a leader in the field of medical hematological diagnostics and coagulation devices.  Please call me and send me your resume in word as a word attachment.

 

Lil Budman

RJ Associates

(914) 946-0278 ext. 106

LilBud@RJSearch.com